Label: 4390 FIRST AID KIT- 4390 first aid kit
4392 FIRST AID KIT- 4392 first aid kit

  • NDC Code(s): 0498-0100-02, 0498-0143-04, 0498-0221-59, 0498-0402-59, view more
    0498-0730-01, 0498-3334-00, 0498-4390-01, 0498-4392-01, 0498-7502-01
  • Packager: Honeywell Safety Products USA, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 13, 2019

If you are a consumer or patient please visit this version.

  • Eyesaline Active ingredient

    Sterile Water 99%

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  • Eyesaline Purpose

    Eyewash

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  • Eyesaline Uses

    • for flushing the eye to remove loose foreign material, air pollutants or chlorinated water
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  • Eyesaline Warnings

    For external use only-

    Obtain immediate medical treatment for all open wounds in or near eyes.

    To avoid contamination, do not touch tip of container to any surface.

    Do not reuse. Once opened, discard.

    Do not use

    • if solution changes color or becomes cloudy
    • if you have open wounds in or near the eyes, get medical help right away.

    Stop use and ask a doctor if

    • you experience eye pain
    • changes in vision
    • continued redness or irritation of the eye
    • condition worsens or persists


    Keep out of reach of children


    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Eyesaline Directions

    • remove contacts before using
    • twist top to remove
    • flush the affected area as needed
    • control rate of flow by pressure on the bottle
    • if necessary, continue flushing with emergency eyewash or shower
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  • Eyesaline Inactive ingredients

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

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  • Eyesaline Questions

    1-800-430-5490 Honeywell Sadety Products USA, Inc. Smithfield, RI 02917

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  • Alcohol Wipe Active ingredient

    Isopropyl alcohol 70%

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  • Alcohol Wipe Purpose

    First aid antiseptic

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  • Alcohol Wipe Uses

    • first aid to help prevent infection in minor cuts, scrapes, and burns
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  • Alcohol Wipe Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body


    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burn


    When using this product

    • do not use longer than one week unless directed by a doctor


    Stop use and consult a doctor

    • if condition persists or gets worse

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
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  • Alcohol Wipe Directions

    • clean the affected area
    • apply wipe to affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • discard wipe after single use
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  • Alcohol Wipe Other information

    store at room temperature 15 0 to 25 0 C (59 0 to 77 0F)

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  • Alcohol Wipe Inactive ingredient

    water

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  • Alcohol Wipe Questions

    1-800-430-5490

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  • Aypanal Active ingredient

    Acetaminophen 325 mg

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  • Aypanal Purpose

    Pain reliever/ fever reducer

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  • Aypanaly Uses

    • temporarily relieves minor aches and pains due to the common cold and headache - temporarily reduces fever
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  • Aypanal Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product:

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • If a skin rash occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription).
    • If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if you have

    • liver disease


    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin


    Stop using and ask a doctor if

    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.


    Overdose warning

    • In case of accidental overdose, get medical help or contact a Poison Control Center right away.
    • Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Keep out of reach of children.

    Keep out of reach of children.

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  • Aypanal Directions

    do not take more than directed (see overdose warning)

    ‚Äčadults and children 12 years of age or older

    • take two tablets every 4-6 hours while symptoms last
    • do not take more than 12 tablets in 24 hours

    children 6 to under 12 years of age

    • take 1 tablet every 4-6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours

    children under 6 years consult a doctor

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  • Aypanal Other information

    • store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
    • TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN
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  • Aypanal Inactive ingredients

    corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

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  • Aypanal Questions

    1-800-430-5490

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  • Neomycin Active ingredient

    Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

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  • Neomycin Purpose

    First aid antibiotic

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  • Neomycin Uses

    • first aid to help prevent infection in - minor cuts - scrapes - burns
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  • Neomycin Warnings


    For external use only

    Do not use

    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns


    Stop use and ask a doctor if

    • a rash or other allergic reaction develops
    • you need to use longer than 1 week

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
    • you need to use longer than 1 week

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away

    Do not use

    • in the eyes
    • over large areas of the body
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  • Neomycin Direction

    • clean the affected area
    • apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
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  • Neomycin Other information


    store at 15 0 to 25 0 C (59 0 to 77 0 F)

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  • Neomycin Inactive ingredient

    petrolatum

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  • Neomycin Questions?

    1-800-430-5490

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  • Antiseptic Spray Active ingredient

    Benzalkonium chloride 0.13%

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  • Antiseptic Spray Purpose

    First aid antiseptic

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  • Antiseptic Spray Uses

    • first aid to help prevent infection in minor cuts, scrapes and burns
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  • Antiseptic Spray Warnings

    For external use only

    Do not use

    • in or near the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use longer than one week unless directed by a doctor

    Stop use and ask a doctor if

    • the condition persists or gets worse

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away
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  • Antiseptic Spray Directions

    • clean the affected area
    • spray a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
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  • Antiseptic Spray Other information

    • shake well
    • store at room temperature 15 0-30 0 C (59 0 -86 0 F)
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  • Antiseptic Spray Inactive ingredients

    diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, water

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  • Antiseptic Spray Questions

    1-800-430-5490

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  • Burn Spray Active ingredient

    Benzethonium chloride 0.2% w/w

    Benzocaine 10% w/w

    Menthol 0.33% w/w

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  • Burn Spray Purpose

    Topical antiseptic

    Topical anesthetic

    Topical antiseptic

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  • Burn Spray Uses

    for the temporary relief of pain and itching and helps protect against infection in:

    • minor cuts and scrapes
    • burns
    • sunburn
    • insect bites
    • minor skin irritations
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  • Burn Spray Warnings

    For external use only

    Flammable

    • keep away from fire or flame
    • contents under pressure
    • do not puncture or incinerate container
    • do not expose to temperatures above 120 0 F

    Do not use

    • in or near the eyes or other mucous membranes
    • in case of serious burns
    • in case of deep or puncture wounds
    • for prolonged period of time
    • on large portion of the body

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • condition clears up and recurs within a few days
    • redness, swelling, or irritation occurs

    Keep out of the reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
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  • Burn Spray Directions

    • clean the affected area
    • shake can well before using
    • hold 4 - 6 inches from surface and spray area until wet
    • may be covered with a sterile bandage, if bandaged let dry first
    • for adult institutional use only
    • not intended for use on children
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  • Burn Spray Other information

    • avoid inhaling
    • use only as directed
    • intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal
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  • Burn Spray Inactive ingredients

    dipropylene glycol, isobutane, n-butane, propane

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  • Hand Sanitizer Active ingredient

    Ethyl alcohol 62%

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  • Hand Santizer Purpose

    Antiseptic handwash

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  • Hand Sanitizer Uses

    • for hand washing to decrease bacteria on skin
    • recommended for repeated use
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  • Hand Sanitizer Warnings

    For external use only

    Flammable, keep away from fire or flame

    When using this product

    • do not use in the eyes
    • discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Hand Sanitizer Directions

    • wet hands thoroughly with product and allow to dry without wiping
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  • Hand Sanitizer Other information

    store at 15 0 to 25 0 C (59 0 to 77 0 F)

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  • Hand Sanitizer Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

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  • Hand Sanitizer Questions or Comments?

    1-800-275-3433 info@waterjel.com www.waterjel.com

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  • Ammonia Active ingredient

    Ammonia 15%

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  • Ammonia Purpose

    Respiratory stimulant

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  • Ammonia Uses

    • to prevent or treat fainting
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  • Ammonia Warnings

    For external use only

    Do not use

    • if you have breathing problems such as asthma or emphysema

    Stop use and ask a doctor if

    • condition persists

    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away.

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  • Ammonia Directions

    • hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated on sleeve.
    • hold near nostrils for inhalation of volatile vapor
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  • Ammonia Other information

    • store at room temperature away from light
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  • Ammonia Inactive ingredients

    alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

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  • Ammonia Questions or Comments?

    1-800-430-5490

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  • Cedaprin Active ingredient

    Ibuprofen 200 mg (NSAID)

    *(nonsteroidal anti-inflammatory drug)

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  • Cedaprin Purposse

    Pain reliever/fever reducer

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  • Cedaprin Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
    • temporarily reduces fever
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  • Cedaprin Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash
    • blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Heart attack and stroke warning:

    • NSAID's, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Do not use

    • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if

    • you have problems or serious side effectsfrom taking pain relievers or fever reducers
    • stomach bleeding warning applies to you
    • you have a history of stomach problems such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
    • you are taking a diuretic

    Ask a doctor or a pharmacist before use if you are

    • taking aspirin for heart attack or stroke, because ibuprofen may decrease the benefit of aspirin
    • under a doctors care for any serious condition
    • taking any other drug

    When using this product,


    take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in oe part or side of body
    • slurred speech
    • leg swelling
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appea

    If pregnant or breast-feeding,


    ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.


    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Cedaprin Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • adult and children 12 years of age and over:
    • take 1 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
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  • Cedaprin Other information

    store between 15 0 -30 0 C (59 0 -86 0 F)
    avoid excessive heat and humidity
    TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

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  • cedaprin Inactive ingredients


    hypromellose, lactose monohydrate, opadry II 31K, povidone K-30, ferric oxide red, silicon dioxide, starch, stearic acid, titanium dioxide, triacetin

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  • Cedaprin Questions or Comments?

    1-800-430-5490

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  • Miralac Active ingredient

    Calcium carbonate 420 mg

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  • Miralac Purpose

    Antacid

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  • Miralac Uses

    for the relief of

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
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  • Miralac Warnings

    Ask a doctor before use if you have

    • kidney stones
    • calcium-restricted diet

    Ask a doctor before use if you are

    presently taking a prescription drug. Antacids may interfere with certain prescription drugs

    When using this product

    do not take more than 12 tablets in a 24- hour period, or use the maximum dosage

    Keep out of the reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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  • Miralac Directions


    chew 1 to 2 tablets every 4 hours as symptoms occur, or as directed by a doctor.

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  • Miralac Other information

    • each tablet contains: calcium 170 mg
    • sucrose free
    • lactose free
    • store at room temperature
    • TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN
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  • Miralac Inactive ingredients

    magnesium stearate, mint flavor, silicon dioxide, sorbitol, starch

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  • Miralac Questions or Comments

    1-800-430-5490

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  • Sinus decongestant Active ingredient

    Phenylephrine HCl 5 mg

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  • Sinus Decongestant Purpose

    Nasal decongestant

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  • Sinus Decongestant Uses

    Temporarily relieves

    • nasal congestion due to:the common cold, hay fever, or other respiratory allergies
    • sinus congestion and pressure.
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  • Sinus Decongestant Warnings

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a health professional before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor if

    • nervousness
    • dizziness
    • sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever

    If pregnant or breast feeding

    ask a health professional

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center immediately

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  • Sinus Decongestant Directions

    • adults and children 12 years of age and over:
    • take 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours
    • children under 12 years, consult a doctor

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  • Sinus Decongestant Other information

    • store at room temperature
    • Tamper Evident Packets
    • do not use if open or torn
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  • Sinus Decongestant Inactive ingredients

    colloidal silica, croscarmellose sodium, D and C Red # 27 Lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, stearic acid, talc

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  • Sinus Decongestant Questions or Comments

    1-800-430-5490

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  • 4392 SF00004422 Kit Contents

    1 1X3 PLASTIC 100/BOX

    1 FINGERTIP "T" WOVEN 40/BOX

    1 SWIFT KNUCKLE 40/BX

    1 1 X 3 WOVEN 100/BOX

    3 NEOMYCIN ANTIBIOTIC 10 PER

    1 AMMONIA INHALANTS 10 PER

    2 EYE DRESS PKT W/4 ADH STRIPS

    1 TOURNIQUET, 1 PER

    1 WIRE SPLINT 1 PER

    1 ADH BAND, EXTRA LARGE, 6 PER

    1 ALCOHOL PREP PADS 10P

    1 O/H PUMP ANTISEPTIC 2 OZ ID F

    1 O/H PUMP BURN RELIEF 2 OZ ID G

    1 FIRST AID GUIDE ASHI

    2 TAPE ADHESIVE 1"X 5 YD PLSTC

    10 HAND SANITIZER 0.9G WJ BULK

    4 GAUZE CLEAN-WRAP BDGE N/S 2"

    4 GAUZE CLEAN-WRAP BDGE N/S 4"

    4 BLOODSTOPPER

    1 NON-ADHERENT PADS 2"X3" 10'S

    1 GZE PADS STERILE 2"X 2" 10'S

    1 GZE PADS STERILE 3"X 3" 25'S

    1 ELASTIC BANDAGE 3" X 4.5YD

    1 CPR FILTERSHIELD 77-100

    1 COTTON TIPS 100 PER VIAL

    1 AYPANAL NON-ASP IND 2/ENV 100

    1 CEDAPRIN (IBUPROFEN) 2ENV 100

    1 MIRALAC TABS IND PK 2/ENV 100

    1 SINUS DECONGESTANT 2/ENV 100

    1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

    1 SCISSOR BDGE 4" RED PLS HDL

    1 KIT TWEEZER 3 1/2" SLANTED

    1 400 EMPTY KIT BLANK

    1 POCKET INSERT RED #400 KIT 5R

    1 TONGUE BLADES SR WRAPPED 6'S

    1 LBL STOCK 6-3/8"X4"

    1 LBL STOCK 4"X2-7/8"

    2 x2 PR LRG NITRILE GLVES ZIP BAG

    2 WATER-JEL BURN DRESSING 4 X 4

    8 CORNER STYROFOAM 3X3X3

    2TRI BNDG NON WOVEN 40"X40"X56"

    2 COLD PACK UNIT 4"X6" BULK

    1 RED BIO BAGS 2/BX

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  • Eyesaline Principal Display Panel
  • Alcohol Wipe Principal Display Panel
  • Aypanal Principal Display Panel
  • Neomycin Principal Display Panel
  • Antiseptic Spray Principal Display Panel
  • Burn Spray Principal Display Panel
  • Hand Sanitizer Principal Display Panel
  • Ammonia Principal Display Panel
  • Cedaprin Principal Display Panel
  • Miralac Principal Display Panel
  • Sinus Decongestant Principal Display Panel
  • 4390 Kit Label FAK4SHLF-CLSB
  • 4390 Kit Contnets FAK4SHLF-CLSB

    1 1X3 PLASTIC 100/BOX

    1 FINGERTIP "T" WOVEN 40/BOX

    1 SWIFT KNUCKLE 40/BX

    1 1 X 3 WOVEN 100/BOX

    3 NEOMYCIN ANTIBIOTIC 10 PER

    1 AMMONIA INHALANTS 10 PER

    2 EYE DRESS PKT W/4 ADH STRIPS

    1 TOURNIQUET, 1 PER

    1 WIRE SPLINT 1 PER

    1 ADH BAND, EXTRA LARGE, 6 PER

    1 ALCOHOL PREP PADS 10P

    1 O/H PUMP ANTISEPTIC 2 OZ ID F

    1 O/H PUMP BURN RELIEF 2 OZ ID G

    1 FIRST AID GUIDE ASHI

    2 TAPE ADHESIVE 1"X 5 YD PLSTC

    10 HAND SANITIZER 0.9G WJ BULK

    4 GAUZE CLEAN-WRAP BDGE N/S 2"

    4 GAUZE CLEAN-WRAP BDGE N/S 4"

    4 BLOODSTOPPER

    1 NON-ADHERENT PADS 2"X3" 10'S

    1 GZE PADS STERILE 2"X 2" 10'S

    1 GZE PADS STERILE 3"X 3" 25'S

    1 ELASTIC BANDAGE 3" X 4.5YD

    1 CPR FILTERSHIELD 77-100

    1 COTTON TIPS 100 PER VIAL

    1 AYPANAL NON-ASP IND 2/ENV 100

    1 CEDAPRIN (IBUPROFEN) 2ENV 100

    1 MIRALAC TABS IND PK 2/ENV 100

    1 SINUS DECONGESTANT 2/ENV 100

    1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

    1 SCISSOR BDGE 4" RED PLS HDL

    1 KIT TWEEZER 3 1/2" SLANTED

    1 POCKET INSERT RED #400 KIT 5R

    1 TONGUE BLADES SR WRAPPED 6'S

    1 LBL STOCK 6-3/8"X4"

    1 LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    4 PR LRG NITRILE GLVES ZIP BAG

    2 WATER-JEL BURN DRESSING 4 X 4

    1 LBL CONTENTS ANSI 2015 CL B

    1 LBL CAB CVR ANSI 2015 CL B

    2 TRI BNDG NON WOVEN 40"X40"X56"

    2 COLD PACK UNIT 4"X6" BULK

    1 RED BIO BAGS 2/BX

    Close
  • 4392 Kit Label SF00004422
  • INGREDIENTS AND APPEARANCE
    4390 FIRST AID KIT 
    4390 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4390
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4390-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE 118 mL
    Part 2 10 POUCH 4 mL
    Part 3 50 PACKET 100 
    Part 4 1 BOTTLE, SPRAY 59 mL
    Part 5 1 BOTTLE, SPRAY 59 mL
    Part 6 30 PACKET 27 g
    Part 7 10 PACKAGE 9 mL
    Part 8 10 AMPULE 3 mL
    Part 9 50 PACKET 100 
    Part 10 50 PACKET 100 
    Part 11 50 PACKET 100 
    Part 1 of 11
    EYESALINE EMERGENCY EYEWASH 
    purified water liquid
    Product Information
    Item Code (Source) NDC:0498-0100
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0100-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 12/18/2018
    Part 2 of 11
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source) NDC:0498-0143
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/18/2018
    Part 3 of 11
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 4 of 11
    BURN RELIEF 
    lidocaine hydrochloride spray
    Product Information
    Item Code (Source) NDC:0498-0221
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 24.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0221-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/18/2018
    Part 5 of 11
    ANTISEPTIC 
    benzalkonium chloride spray
    Product Information
    Item Code (Source) NDC:0498-0402
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0402-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 09/18/2018
    Part 6 of 11
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 7 of 11
    INSTANT HAND SANITIZER 
    alcohol liquid
    Product Information
    Item Code (Source) NDC:59898-420
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    WATER (UNII: 059QF0KO0R)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 04/15/2010
    Part 8 of 11
    AMMONIA INHALENT 
    ammonia inhalent inhalant
    Product Information
    Item Code (Source) NDC:0498-3334
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g  in 0.3 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-3334-00 0.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/18/2018
    Part 9 of 11
    MIRALAC 
    calcium carbonate tablet
    Product Information
    Item Code (Source) NDC:0498-0303
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 420 mg
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white (white) Score 2 pieces
    Shape ROUND Size 11mm
    Flavor MINT (mint flavor) Imprint Code FR8
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 02/22/2012
    Part 10 of 11
    SINUS DECONGESTANT 
    phenylephrine tablet
    Product Information
    Item Code (Source) NDC:0498-3331
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color red (red) Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code FR4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/18/2018
    Part 11 of 11
    CEDAPRIN 
    ibuprofen tablet
    Product Information
    Item Code (Source) NDC:0498-7502
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TRIACETIN (UNII: XHX3C3X673)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Color red Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code G;2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-7502-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079129 01/02/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4392 FIRST AID KIT 
    4392 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4392
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4392-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 50 PACKET 100 
    Part 2 1 BOTTLE 118 mL
    Part 3 10 POUCH 4 mL
    Part 4 50 PACKET 100 
    Part 5 1 BOTTLE, SPRAY 59 mL
    Part 6 1 BOTTLE, SPRAY 59 mL
    Part 7 30 PACKET 27 g
    Part 8 10 PACKAGE 9 mL
    Part 9 10 AMPULE 3 mL
    Part 10 50 PACKET 100 
    Part 11 50 PACKET 100 
    Part 1 of 11
    CEDAPRIN 
    ibuprofen tablet
    Product Information
    Item Code (Source) NDC:0498-7502
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TRIACETIN (UNII: XHX3C3X673)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Color red Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code G;2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-7502-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079129 01/02/2017
    Part 2 of 11
    EYESALINE EMERGENCY EYEWASH 
    purified water liquid
    Product Information
    Item Code (Source) NDC:0498-0100
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0100-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 12/18/2018
    Part 3 of 11
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source) NDC:0498-0143
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/18/2018
    Part 4 of 11
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 5 of 11
    BURN RELIEF 
    lidocaine hydrochloride spray
    Product Information
    Item Code (Source) NDC:0498-0221
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 24.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0221-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/18/2018
    Part 6 of 11
    ANTISEPTIC 
    benzalkonium chloride spray
    Product Information
    Item Code (Source) NDC:0498-0402
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0402-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 09/18/2018
    Part 7 of 11
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 8 of 11
    INSTANT HAND SANITIZER 
    alcohol liquid
    Product Information
    Item Code (Source) NDC:59898-420
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    WATER (UNII: 059QF0KO0R)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 04/15/2010
    Part 9 of 11
    AMMONIA INHALENT 
    ammonia inhalent inhalant
    Product Information
    Item Code (Source) NDC:0498-3334
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g  in 0.3 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-3334-00 0.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/18/2018
    Part 10 of 11
    MIRALAC 
    calcium carbonate tablet
    Product Information
    Item Code (Source) NDC:0498-0303
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 420 mg
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white (white) Score 2 pieces
    Shape ROUND Size 11mm
    Flavor MINT (mint flavor) Imprint Code FR8
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 02/22/2012
    Part 11 of 11
    SINUS DECONGESTANT 
    phenylephrine tablet
    Product Information
    Item Code (Source) NDC:0498-3331
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color red (red) Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code FR4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/18/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    Labeler - Honeywell Safety Products USA, INC (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    James Alexander 040756421 manufacture(0498-3334)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, INC 079287321 pack(0498-4390, 0498-4392)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 manufacture(0498-2001, 0498-0303, 0498-3331)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(0498-0730, 0498-0402, 0498-0221, 59898-420)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100)
    Establishment
    Name Address ID/FEI Business Operations
    Changzhou Maokang Medical 421317073 manufacture(0498-0143)
    Establishment
    Name Address ID/FEI Business Operations
    Granules of India Limited 918609236 manufacture(0498-7502)
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