4390 FIRST AID KIT- 4390 first aid kit 
4392 FIRST AID KIT- 4392 first aid kit 
Honeywell Safety Products USA, INC

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.

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0498-4390 & 0498-4392: First Aid Kit (Neomycin, ammonia inh, alcohol wipes, Burn Sray, Antiseptic Spray, Hand Sanitizer, aypanal, cedaprin, miralac, sinus decongest, EW- FAK4SHLF-CLSB, SF00004422)

Eyesaline
Active ingredient

Sterile Water 99%

Eyesaline
Purpose

Eyewash

Eyesaline
Uses

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

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.

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

Eyesaline
Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyesaline
Questions

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

Alcohol Wipe
Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe
Purpose

First aid antiseptic

Alcohol Wipe
Uses

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

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.

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

Alcohol Wipe
Other information

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

Alcohol Wipe
Inactive ingredient

water

Alcohol Wipe
Questions

1-800-430-5490

Aypanal
Active ingredient

Acetaminophen 325 mg

Aypanal
Purpose

Pain reliever/ fever reducer

Aypanaly
Uses

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

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.

Aypanal
Directions

do not take more than directed (see overdose warning)

​adults 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

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

Aypanal
Inactive ingredients

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

Aypanal
Questions

1-800-430-5490

Neomycin
Active ingredient

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

Neomycin
Purpose

First aid antibiotic

Neomycin
Uses

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

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

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

Neomycin
Other information


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

Neomycin
Inactive ingredient

petrolatum

Neomycin
Questions?

1-800-430-5490

Antiseptic Spray
Active ingredient

Benzalkonium chloride 0.13%

Antiseptic Spray
Purpose

First aid antiseptic

Antiseptic Spray
Uses

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

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

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

Antiseptic Spray
Other information

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

Antiseptic Spray
Inactive ingredients

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

Antiseptic Spray
Questions

1-800-430-5490

Burn Spray
Active ingredient

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Spray
Purpose

Topical antiseptic

Topical anesthetic

Topical antiseptic

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

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.

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

Burn Spray
Other information

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

Burn Spray
Inactive ingredients

dipropylene glycol, isobutane, n-butane, propane

Hand Sanitizer
Active ingredient

Ethyl alcohol 62%

Hand Santizer
Purpose

Antiseptic handwash

Hand Sanitizer
Uses

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

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.

Hand Sanitizer
Directions

  • wet hands thoroughly with product and allow to dry without wiping

Hand Sanitizer
Other information

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

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

Hand Sanitizer
Questions or Comments?

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

Ammonia
Active ingredient

Ammonia 15%

Ammonia
Purpose

Respiratory stimulant

Ammonia
Uses

  • to prevent or treat fainting

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.

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

Ammonia
Other information

  • store at room temperature away from light

Ammonia
Inactive ingredients

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

Ammonia
Questions or Comments?

1-800-430-5490

Cedaprin
Active ingredient

Ibuprofen 200 mg (NSAID)

*(nonsteroidal anti-inflammatory drug)

Cedaprin
Purposse

Pain reliever/fever reducer

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

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.

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

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

cedaprin
Inactive ingredients


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

Cedaprin
Questions or Comments?

1-800-430-5490

Miralac
Active ingredient

Calcium carbonate 420 mg

Miralac
Purpose

Antacid

Miralac
Uses

for the relief of

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

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.

Miralac
Directions


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

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

Miralac
Inactive ingredients

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

Miralac
Questions or Comments

1-800-430-5490

Sinus decongestant
Active ingredient

Phenylephrine HCl 5 mg

Sinus Decongestant
Purpose

Nasal decongestant

Sinus Decongestant
Uses

Temporarily relieves

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

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

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

Sinus Decongestant
Other information

  • store at room temperature
  • Tamper Evident Packets
  • do not use if open or torn

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

Sinus Decongestant
Questions or Comments

1-800-430-5490

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

Eyesaline
Principal Display Panel

Eyesaline

Alcohol Wipe
Principal Display Panel

OH Pak Alcohol Wipe

Aypanal
Principal Display Panel

Aypanal

Neomycin
Principal Display Panel

Neomycin

Antiseptic Spray
Principal Display Panel

Antiseptic Spray

Burn Spray
Principal Display Panel

Burn Spray

Hand Sanitizer
Principal Display Panel

Hand Sanitizer

Ammonia
Principal Display Panel

Ammonia Inhalant

Cedaprin
Principal Display Panel

Cedaprin

Miralac
Principal Display Panel

Miralac

Sinus Decongestant
Principal Display Panel

Sinus Decongestant

4390 Kit Label
FAK4SHLF-CLSB

4390 label

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

4392 Kit Label
SF00004422

4392 Label

4390 FIRST AID KIT 
4390 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4390
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4390-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 210 POUCH 4 mL
Part 350 PACKET 100 
Part 41 BOTTLE, SPRAY 59 mL
Part 51 BOTTLE, SPRAY 59 mL
Part 630 PACKET 27 g
Part 710 PACKAGE 9 mL
Part 810 AMPULE 3 mL
Part 950 PACKET 100 
Part 1050 PACKET 100 
Part 1150 PACKET 100 
Part 1 of 11
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 11
ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:0498-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 3 of 11
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 4 of 11
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 5 of 11
ANTISEPTIC 
benzalkonium chloride spray
Product Information
Item Code (Source)NDC:0498-0402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 6 of 11
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 7 of 11
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2010
Part 8 of 11
AMMONIA INHALENT 
ammonia inhalent inhalant
Product Information
Item Code (Source)NDC:0498-3334
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-3334-000.3 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 9 of 11
MIRALAC 
calcium carbonate tablet
Product Information
Item Code (Source)NDC:0498-0303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (white) Score2 pieces
ShapeROUNDSize11mm
FlavorMINT (mint flavor) Imprint Code FR8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/22/2012
Part 10 of 11
SINUS DECONGESTANT 
phenylephrine tablet
Product Information
Item Code (Source)NDC:0498-3331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorred (red) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code FR4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 11 of 11
CEDAPRIN 
ibuprofen tablet
Product Information
Item Code (Source)NDC:0498-7502
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-7502-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201809/22/2021
4392 FIRST AID KIT 
4392 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4392
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4392-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 150 PACKET 100 
Part 21 BOTTLE 118 mL
Part 310 POUCH 4 mL
Part 450 PACKET 100 
Part 51 BOTTLE, SPRAY 59 mL
Part 61 BOTTLE, SPRAY 59 mL
Part 730 PACKET 27 g
Part 810 PACKAGE 9 mL
Part 910 AMPULE 3 mL
Part 1050 PACKET 100 
Part 1150 PACKET 100 
Part 1 of 11
CEDAPRIN 
ibuprofen tablet
Product Information
Item Code (Source)NDC:0498-7502
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-7502-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/02/2017
Part 2 of 11
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 3 of 11
ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:0498-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 4 of 11
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 5 of 11
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 6 of 11
ANTISEPTIC 
benzalkonium chloride spray
Product Information
Item Code (Source)NDC:0498-0402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 7 of 11
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 8 of 11
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2010
Part 9 of 11
AMMONIA INHALENT 
ammonia inhalent inhalant
Product Information
Item Code (Source)NDC:0498-3334
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-3334-000.3 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 10 of 11
MIRALAC 
calcium carbonate tablet
Product Information
Item Code (Source)NDC:0498-0303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (white) Score2 pieces
ShapeROUNDSize11mm
FlavorMINT (mint flavor) Imprint Code FR8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/22/2012
Part 11 of 11
SINUS DECONGESTANT 
phenylephrine tablet
Product Information
Item Code (Source)NDC:0498-3331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorred (red) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code FR4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201802/17/2020
Labeler - Honeywell Safety Products USA, INC (118768815)

Revised: 1/2024
 
Honeywell Safety Products USA, INC