Label: 4209 FIRST AID KIT- 4209 first aid kit
4211 FIRST AID KIT- 4211 first aid kit

  • NDC Code(s): 0498-0011-77, 0498-0100-01, 0498-0114-01, 0498-0501-00, view more
    0498-0750-35, 0498-3334-00, 0498-4209-01, 0498-4211-01
  • 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 18, 2019

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

  • Eyewash Active ingredient

    Sterile Water 99%

    Close
  • Eyewash Purpose

    Eyewash

    Close
  • Eyewash Uses

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

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

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  • Eyewash Questions

    1-800-430-5490

    Close
  • Triple Active ingredient (each gram contains)

    Bacitracin zinc 400 units - Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base) Polymyxin B sulfate 5000 units

    Close
  • 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
    Close
  • 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

    Close
  • Triple Inactive ingredient

    petrolatum

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  • Triple Questions

    1-800-430-5490

    Close
  • 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.
    Close
  • 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
    Close
  • Aspirin Other information

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

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

    Close
  • Ammonia Questions or Comments?

    1-800-430-5490

    Close
  • Pyrocaine Active ingredient

    Benzocaine 20%

    Benzethonium chloride 0.2%

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  • Pyrocaine Purpose

    Topical anesthetic

    Topical antiseptic

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  • Pyrocaine Uses

    For the temporary relief of pain and itching, and to help protect against skin infection in:

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

    Do not use

    • in or near the eyes or over large portions of the body
    • in case of deep or puncture wounds or on:
    • raw surfaces
    • blistered areas
    • animal bites
    • serious burns

    Keep out of reach of children

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

    For external use only

    Flammable

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

    Stop use and ask a doctor if

    • If condition persists or worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    Close
  • Pyrocaine Directions

    • clean the affected area
    • shake can well before using
    • hold can 6 to 12 inches away from the affected area and spray liberally
    • apply to affected area not more than 3 times daily
    • for adult institutional use only
    • not intended for use on children
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  • Pyrocaine 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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  • Pyrocaine Inactive ingredients


    butane,dipropylene glycol, isobutane, propane

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  • BZK Wipes Active ingredient

    Benzalkonium chloride 0.13% w/v

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  • BZK Wipe Purpose

    First aid antiseptic

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  • BZK Wipes Uses

    • Antiseptic cleansing of face, hands, and body without soap and water
    Close
  • BZK Wipes Warnings

    For external use only

    Do not use

    • in the eyes or over large areas of the body
    • on mucous membranes
    • on irritated skin
    • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
    • longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • if irritation, redness or other symptoms develop
    • 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.
    Close
  • BZK Wipe Directions

    • tear open packet and use as a washcloth
    Close
  • BzK Wipe Other information

    • store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
    • do not reuse towelette
    Close
  • BZK Wipe Inactive ingredient

    water

    Close
  • BZK Wipe Questions

    1-800-430-5490

    Close
  • 4209 340001F Kit Contents

    1 3/4X3 PLAS SING 50/BOX

    1 GAUZE BANDAGE, 4" X 6 YD

    1 ADH TAPE W/P 1/2"X 2 1/2 YD

    1 GAUZE CLEAN-WRAP BDGE N/S 2"

    1 PYRO-CAINE AEROSOL 1/2 OZ

    1 1 OZ, BUFF EYEWASH

    1 SCISSOR BDGE 4" RED PLS HDL

    1 KIT TWEEZER 3 1/2" SLANTED

    1 F. A. INST CHART SM (INDIVIDUAL LBL)

    LBL STOCK 6-3/8"X4"

    1 LBL STOCK 3"x1-7/8"

    2 BAYER 12 PACK PER ZIP BAG

    1 1ST AID PK 0001 0002 110 amm,bzk, triple

    1 KIT, PP 10 UNIT FA

    Close
  • 4211 340002L Kit Contents

    1 3/4X3 PLAS SING 50/BOX

    1 ADH TAPE W/P 1/2"X 2 1/2 YD

    1 GAUZE CLEAN-WRAP BDGE N/S 2"

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

    1 PYRO-CAINE AEROSOL 1/2 OZ

    1 1 OZ, BUFF EYEWASH

    1 SCISSOR BDGE 4" RED PLS HDL

    1 KIT TWEEZER 3 1/2" SLANTED

    1 F. A. INST CHART SM (INDIVIDUAL LBL)

    LBL STOCK 6-3/8"X4"

    1 LBL STOCK 3"x1-7/8"

    2 BAYER 12 PACK PER ZIP BAG

    1 1ST AID PACK FOR 0001 0002 110

    1 KIT, PP 10 UNIT FA

    Close
  • Eyewash Principal Display Panel
  • Triple Principal Display Panel
  • Aspirin Principal Display Panel
  • Ammonia Principal Display Panel
  • Pyrocaine Principal Display Panel
  • BZK Wipe Principal Display Panel
  • 4209 Kit Label 340001F
  • 4211 Kit Label 340002F
  • INGREDIENTS AND APPEARANCE
    4209 FIRST AID KIT 
    4209 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4209
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4209-01 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 30 mL
    Part 2 6 PACKET 8.4 mL
    Part 3 12 PACKET 24 
    Part 4 4 PACKET 3.6 g
    Part 5 2 AMPULE 0.6 mL
    Part 6 1 CAN 14.2 g
    Part 1 of 6
    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 6
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0501-00 1.4 mL 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 part333E 12/21/2017
    Part 3 of 6
    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 4 of 6
    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
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [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 5 of 6
    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 6 of 6
    PYROCAINE BURN 
    benzocaine, benzethonium chloride aerosol, spray
    Product Information
    Item Code (Source) NDC:0498-0011
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g  in 100 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    1,1,3-TRI(3-TERT-BUTYL-4-HYDROXY-6-METHYLPHENYL)BUTANE (UNII: BF6E9O0XJN)  
    ISOBUTANE (UNII: BXR49TP611)  
    1,1,3-TRIS(2-CHLOROETHOXY)PROPANE (UNII: 4FEX9N888E)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0011-77 14.2 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 01/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4211 FIRST AID KIT 
    4211 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4211
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4211-01 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 30 mL
    Part 2 6 PACKET 8.4 mL
    Part 3 12 PACKET 24 
    Part 4 4 PACKET 3.6 g
    Part 5 2 AMPULE 0.6 mL
    Part 6 1 CAN 14.2 g
    Part 1 of 6
    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 6
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0501-00 1.4 mL 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 part333E 12/21/2017
    Part 3 of 6
    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 4 of 6
    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
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [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 5 of 6
    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 6 of 6
    PYROCAINE BURN 
    benzocaine, benzethonium chloride aerosol, spray
    Product Information
    Item Code (Source) NDC:0498-0011
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g  in 100 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    1,1,3-TRI(3-TERT-BUTYL-4-HYDROXY-6-METHYLPHENYL)BUTANE (UNII: BF6E9O0XJN)  
    ISOBUTANE (UNII: BXR49TP611)  
    1,1,3-TRIS(2-CHLOROETHOXY)PROPANE (UNII: 4FEX9N888E)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0011-77 14.2 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 01/01/2018
    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(0498-4209, 0498-4211)
    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(0498-0011)
    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(0498-0501)
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