Label: 4232 FIRST AID KIT- 4232 first aid kit
4221 FIRST AID KIT- 4221 first aid kit

  • NDC Code(s): 0498-0021-40, 0498-0031-40, 0498-0100-01, 0498-0100-02, view more
    0498-0114-01, 0498-0143-04, 0498-0750-35, 0498-0750-36, 0498-3334-00, 0498-4221-01, 0498-4232-01
  • 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 March 30, 2019

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

  • Eyewash Active ingredient

    Sterile Water 99%

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  • Eyewash Purpose

    Eyewash

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  • Eyewash Uses

    • for flushing the eye to remove loose foreign material, air pollutants or chlorinated water
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  • Eyewash 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.
    Close
  • Eyewash 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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  • Eyewash Inactive ingredients

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

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  • Eyewash Questions

    1-800-430-5490

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  • Aspirin Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

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  • Aspirin Purpose

    Pain reliever/fever reducer

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  • Aspirin Uses

    temporarily reduces fever and relieves minor aches and pains associated with:

    • a cold
    • headache
    • toothache
    • muscular aches
    • backache
    • minor pain of arthritis
    • premenstrual and menstrual periods
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  • Aspirin Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    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

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if

    • 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 or kidney disease
    • you are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout or arthritis

    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
    • 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
    • ringing in the ears or loss of hearing occurs
    • any new symptoms appear

    If pregnant or breast-feeding,

    If pregnant or breat-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three 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.

    • In case of overdose, get medical help or contact Poison Control Center right away.
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  • Aspirin Directions

    • drink a full glass of water with each dose
    • adults and children 12 years of age and older: take 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
    • children under 12 years of age: consult a doctor
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  • Aspirin Other information

    • store at room temperature 15° - 30°C (59° - 86°F)
    • TAMPER EVIDIENT PACKETS
    • DO NOT USE IF OPEN OR TORN
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  • Aspirin Inactive ingredients

    corn starch, croscarmellose sodium*, hypromellose*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, propylene glycol, silicon dioxide, stearic acid*, titanium dioxide*

    *may contain these ingredients

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  • Aspirin Questions or Comments

    1-800-430-5490

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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 ingredient

    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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  • Water Soluble 1st Aid Spray Active ingredient

    Benzethonium chloride 0.2% w/w - Benzocaine 10% w/w

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  • Water Soluble 1st Aid Spray Purpose

    Topical antiseptic

    Topical anesthetic

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  • Water Soluble 1st Aid Spray Uses

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

    • minor cuts and scrapes
    • insect bites
    • minor skin irritations

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  • Water Soluble 1st Aid 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 temperature above 120 0 F

    Do not use

    • in the eyes or other mucous membranes
    • in cases of serious burns
    • in case of deep orpuncture wounds
    • for a 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 occurs again within a few days
    • redness, swelling, or irritation occurs

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away
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  • Water Soluble 1st Aid 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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  • Water Soluble 1st Aid pray Other information

    • avoid inhaling
    • use only as directed
    • intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal
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  • Water Soluble 1st Aid pray Inactive ingredients


    dipropylene glycol, isobutane, N-butane, propane

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  • Burn Relief Water Soluble Active ingredients

    Benzethonium chloride 0.2% w/w

    Benzocaine 10% w/w

    Menthol 0.33% w/w

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  • Burn Relief Water Soluble Purpose


    Topical antiseptic

    Topical anesthetic

    Topical anesthetic

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  • Burn Relief Water Soluble 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 Relief Water Soluble 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.

    Close
  • Burn Relief Water Soluble 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 Relief Water Soluble 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 Relief Water Soluble Inactive ingredients

    dipropylene glycol, isobutane, n-butane, propane

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  • Triple Active ingredients

    Bacitracin zinc 400 units

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

    Polymyxin B sulfate 5000 units

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  • Triple Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

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  • Triple Uses

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

    For external use only

    Allergy alert do not use if you are allergic to any of the ingredients

    Do not use

    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • a deep or puncture wounds
    • animal bites
    • serious burns


    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 the reach of children

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

    Close
  • Triple Directions

    • 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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  • Triple Other information

    • store at 15 0 to 25 0 C (59 0 to 77 0 F)
    • tamper evident sealed packets
    • do not use if packet is torn or opened
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  • Triple Inactive ingredient

    petrolatum

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  • Alcohol Active ingredient

    Isopropyl alcohol 70%

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  • Alcohol Purpose

    First aid antiseptic

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  • Alcohol Uses

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

    For external use only

    Flammable, keep away from fire or flame.

    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

    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.
    Close
  • Alcohol 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 Other information

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

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  • Alcohol Inactive ingredient

    water

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  • 4221 340460F KIT CONTENTS

    1 3/4 X 3 PLAS 100/BOX

    1 AMMONIA INHALANTS 10 PER

    1 INSTANT COLD PACK 4" X 6"

    1 ADHESIVE TAPE W/P 1/2"X 5 YD

    1 FIRST AID GUIDE ASHI

    1 GAUZE CLEAN-WRAP BDGE N/S 2"

    1 BLOODSTOPPER

    1 CO-FLEX BANDAGE 2"X 5YDS TAN

    1 FIRST AID SPRAY AEROSOL 3 OZ

    1 BURN SPRAY 3 OZ

    1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

    1 SCISSOR BDGE 4" RED PLS HDL

    1 KIT TWEEZER 3 1/2" SLANTED

    LBL STOCK 6-3/8"X4"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 PR LRG NITRILE GLVES ZIP BAG

    2 BAYER 12 PACK PER ZIP BAG

    2 TRIPLE BIOTIC FOIL PACK EACH

    6 WIPE ALCOHOL PREP IPA 70% (DUKAL)

    1 KIT STL 36 UN WHT 01 HOR SHELF

    1 TRI BNDG NON WOVEN 40"X40"X56"

    10 NON ADHERENT PAD 2" X 3"

    1 WOVEN KNUCKLE 8'S

    1 FINGERTIP "T" 8/BX

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  • 4232 68180LBR Kit Contents

    1 3/4 X 3 PLAS 100/BOX

    1 1X3 PLASTIC 100/BOX

    1 FINGERTIP "T" WOVEN 40/BOX

    1 1X3 WOVEN SING 50/BOX

    1 SWIFT KNUCKLE 40/BX

    1 AMMONIA INHALANTS 10 PER

    1 INSTANT COLD PACK 4" X 6"

    1 ELASTIC TAPE 1" X 5YD

    1 FORCEPS POINTED METAL

    1 O/H TAPE ADHESIVE TRI-CUT

    1 FIRST AID GUIDE ASHI

    4 GAUZE CLEAN-WRAP BDGE N/S 2"

    2 BLOODSTOPPER

    1 NON ADHERENT PADS 2"X3" 50'S

    2 GZE PADS STERILE 2"X 2" 25'S

    1 GZE PADS STERILE 4"X 4" 25'S

    1 CO-FLEX BANDAGE 2"X 5YDS TAN

    1 COTTON TIPS 100 PER VIAL

    1 ANTISEPTIC WIPES BZK CHL 20'S

    1 FIRST AID SPRAY AEROSOL 3 OZ

    1 ALCOHOL WIPES 50'S

    1 ASPIRIN IND PK 5 GR 2/ENV 250

    1 BURN SPRAY 3 OZ

    1 TRIPLE BIOTIC .5 GRAM PKT 20

    4 1 OZ, BUFF EYEWASH

    1 SCISSOR BDGE 4" RED PLS HDL

    1 180 EMPTY BLANK NO LOGO

    1 POCKET INSERT RED #180 KIT 4R

    1 TONGUE BLADES SR WRAPPED 6'S

    1 LBL STOCK 6-3/8"X4"

    1 LBL STOCK 4"X2-7/8"

    2 PR LRG NITRILE GLVES ZIP BAG

    2 TRI BNDG NON WOVEN 40"X40"X56"

    1 RED BIO BAGS 2/BX

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  • Eyewash Principal Display Panel
  • Aspirin Principal Display Panel
  • Ammonia Principal Display Panel
  • Water Soluble 1st Aid Spray Principal Display Panel
  • Burn Relief Water Soluble Principal Display Panel
  • Triple Principal Display Panel
  • Alcohol Principal Display Panel
  • 4221 Kit Label 340460F
  • 4232 Kit Label 68180LBR
  • INGREDIENTS AND APPEARANCE
    4232 FIRST AID KIT 
    4232 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4232
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4232-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 4 BOTTLE 120 mL
    Part 2 125 PACKET 250 
    Part 3 10 AMPULE 3 mL
    Part 4 1 CAN 85 g
    Part 5 1 CAN 85 g
    Part 6 20 PACKET 10 g
    Part 7 50 POUCH 20 mL
    Part 1 of 7
    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, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0100-01 30 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 7
    ASPIRIN 
    aspirin tablet
    Product Information
    Item Code (Source) NDC:0498-0114
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code FR21
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0114-01 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
    OTC monograph not final part343 09/18/2018
    Part 3 of 7
    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 4 of 7
    FIRST AID ANTISEPTIC WATER SOLUBLE 
    benzethonium chloride, benzocaine spray
    Product Information
    Item Code (Source) NDC:0498-0031
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0031-40 85 g in 1 CAN; 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 09/19/2018
    Part 5 of 7
    BURN WATER SOLUBLE 
    benzocaine, benzethonium chloride, menthol spray
    Product Information
    Item Code (Source) NDC:0498-0021
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.33 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0021-40 85 g in 1 CAN; 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 11/12/2018
    Part 6 of 7
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Item Code (Source) NDC:0498-0750
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0750-36 0.5 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 09/19/2018
    Part 7 of 7
    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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4221 FIRST AID KIT 
    4221 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4221
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4221-01 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 12 PACKET 24 
    Part 3 1 AMPULE 0.3 mL
    Part 4 1 CAN 85 g
    Part 5 1 CAN 85 g
    Part 6 2 PACKET 1.8 g
    Part 7 6 POUCH 2.4 mL
    Part 1 of 7
    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, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    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 7
    ASPIRIN 
    aspirin tablet
    Product Information
    Item Code (Source) NDC:0498-0114
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code FR21
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0114-01 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
    OTC monograph not final part343 09/18/2018
    Part 3 of 7
    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 4 of 7
    FIRST AID ANTISEPTIC WATER SOLUBLE 
    benzethonium chloride, benzocaine spray
    Product Information
    Item Code (Source) NDC:0498-0031
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0031-40 85 g in 1 CAN; 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 09/19/2018
    Part 5 of 7
    BURN WATER SOLUBLE 
    benzocaine, benzethonium chloride, menthol spray
    Product Information
    Item Code (Source) NDC:0498-0021
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.33 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0021-40 85 g in 1 CAN; 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 11/12/2018
    Part 6 of 7
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Item Code (Source) NDC:0498-0750
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0750-35 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 09/19/2018
    Part 7 of 7
    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
    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(0498-4221, 0498-4232)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 manufacture(0498-0114)
    Establishment
    Name Address ID/FEI Business Operations
    Dixon Investments 115315822 manufacture(0498-0031, 0498-0021)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(0498-0750)
    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)
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