Label: 4227 FIRST AID KIT- 4227 first aid kit
4228 FIRST AID KIT- 4228 first aid kit
4225 FIRST AID KIT- 4225 first aid kit
4251 FIRST AID KIT- 4251 first aid kit

  • NDC Code(s): 0498-0114-01, 0498-0143-04, 0498-0733-00, 0498-3334-00, view more
    0498-4225-01, 0498-4227-01, 0498-4228-01, 0498-4251-01
  • 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 April 7, 2019

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

  • First Aid Burn Cream Active ingredient

    Benzalkonium chloride o.13%

    Lidocaine HCl 0.5%

    Close
  • First Aid Burn Cream Purpose

    First aid antiseptic

    External analgesic

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  • First Aid Burn Cream Uses

    • prevent skin infection
    • for temporary relief of pain associated with minor burns
    Close
  • First Aid Burn Cream Warnings

    For external use only

    Do not use

    • in or near the eyes
    • if you are allergic to any of the ingredients
    • in large areas of the body, particularly over raw surfaces or blistered areas
    • for more than 10 days


    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
    Close
  • First Aid Burn Cream Directions

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: consult a doctor
    Close
  • First Aid Burn Cream Other information

    • tamper evident sealed packets
    • do not use if packet is opened or torn
    Close
  • First Aid Burn Cream Inactive ingredients

    aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

    Close
  • First Aid Burn Cream Questions

    1-800-430-5490

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  • Alcohol Wipe Active ingredient

    Isopropyl alcohol 70%

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  • Alcohol Wipe Purpose

    First aid antiseptic

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  • Alcohol Wipe Uses

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

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body


    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burn


    When using this product

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


    Stop use and consult a doctor

    • if condition persists or gets worse

    Keep out of reach of children

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

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

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

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  • Alcohol Wipe Inactive ingredient

    water

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  • Alcohol Wipe Questions

    1-800-430-5490

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  • 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
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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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  • Sting Relief Active ingredient (in each wipe)

    Ethyl alcohol 50.0% Lidocaine HCl 2.0%

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  • Sting Relief Purpose

    Antiseptic - Topical pain relief

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  • Sting Relief Uses

    • prevent infection in minor scrapes, and temporary relief of itching of insect bites
    Close
  • Sting Relief Warnings

    For external use only
    Flammable, keep away from open fire or flame

    Do not use

    • over large areas of the body
    • in eyes
    • over raw or blistered areas

    Stop use and ask a doctor

    • if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

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

    Close
  • Sting Relief Directions

    adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.
    children under 2 years of age: consult a doctor.

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  • Sting Relief Inactive ingredients


    benzalkonium chloride, menthol, and purified water

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  • Sting Relief Questios 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 ingredients

    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
  • 4225 662010P Kit Contents

    1 INSTANT COLD PACK 4" X 6"

    1 ADHESIVE BDG,PLSTIC,1"X3"16PER

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

    1 GAUZE CLEAN-WRAP BDGE N/S 2"

    1 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"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 PR LRG NITRILE GLVES ZIP BAG

    1 FIRST AID CREAM FOIL PKS 16/BG

    1 12 ASPIRIN TABLETS (6 2/PKS)

    3 WIPE ALCOHOL PREP IPA 70% (DUKAL)

    1 KIT, PP 10 UNIT FA

    2 ADHES TAPE EYE STRIPS 2'S

    3 SAFETEC STING RELIEF WIPES BULK

    1 TRI BNDG NON WOVEN 40"X40"X56"

    2 EYE PADS STD OVAL STERILE

    5 GAUZE PADS 4"X4" 12PLY

    3 AMMONIA INHALANT, BULK

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  • 4227 6810BR Kit Contents

    1 INSTANT COLD PACK 4" X 6"

    1 ADH BDG,PLSTIC,3/4"X3",16 PER

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

    1 GAUZE CLEAN-WRAP BDGE N/S 2"

    1 FIRST AID CREAM 0.9 GRM PKT 20

    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"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 PR LRG NITRILE GLVES ZIP BAG

    3 WIPE ALCOHOL PREP IPA 70% (DUKAL)

    1 KIT STL 10 UN WHITE 01

    2 ADHES TAPE EYE STRIPS 2'S

    3 SAFETEC STING RELIEF WIPES BULK

    1 TRI BNDG NON WOVEN 40"X40"X56"

    2 EYE PADS STD OVAL STERILE

    5 GAUZE PADS 4"X4" 12PLY

    6 ASPIRIN BULK 2/PK

    3 AMMONIA INHALANT, BULK

    Close
  • 4228 6810PMD Kit Contents

    1 INSTANT COLD PACK 4" X 6"

    1 ADH BDG,PLSTIC,3/4"X3",16 PER

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

    1 GAUZE CLEAN-WRAP BDGE N/S 2"

    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"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 PR LRG NITRILE GLVES ZIP BAG

    1 FIRST AID CREAM FOIL PKS 16/BG

    12 ASPIRIN TABLETS (6 2/PKS)

    3 WIPE ALCOHOL PREP IPA 70% (DUKAL)

    1 KIT, PP 10 UNIT FA

    2 ADHES TAPE EYE STRIPS 2'S

    3 SAFETEC STING RELIEF WIPES BULK

    1 TRI BNDG NON WOVEN 40"X40"X56"

    2 EYE PADS STD OVAL STERILE

    5 GAUZE PADS 4"X4" 12PLY

    1 ZIP-LOCK BAG 5" X 5" .002

    3 AMMONIA INHALANT, BULK

    Close
  • 4251 68P10BR kit contents

    1 INSTANT COLD PACK 4" X 6"

    1 ADHESIVE BDG,PLSTIC,1"X3"16PER

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

    1 GAUZE CLEAN-WRAP BDGE N/S 2"

    1 FIRST AID CREAM 0.9 GRM PKT 20

    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"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 PR LRG NITRILE GLVES ZIP BAG

    3 WIPE ALCOHOL PREP IPA 70% (DUKAL)

    1 KIT, PP 10 UNIT FA

    1 SAFETEC STING RELIEF WIPES BULK

    1 TRI BNDG NON WOVEN 40"X40"X56"

    5 GAUZE PADS 3"X3" 12PLY

    6 ASPIRIN BULK 2/PK

    3 AMMONIA INHALANT, BULK

    Close
  • First Aid Burn Cream Principal Display Panel
  • Alcohol Wipe Label
  • Aspirin Principal Display Panel
  • Sting Relief Principal Display Panel
  • Ammonia Principal Display Panel
  • 4225 Kit Label 662010P
  • 4227 Kit Label 6810BR
  • 4228 Kit Label 6810PMD
  • 4251 Kit Label 68P10BR
  • INGREDIENTS AND APPEARANCE
    4227 FIRST AID KIT 
    4227 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4227
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4227-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 20 PACKET 18 g
    Part 2 3 POUCH 1.2 mL
    Part 3 6 PACKET 12 
    Part 4 3 POUCH 1.2 mL
    Part 5 3 AMPULE 0.9 mL
    Part 1 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 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 not final part333A 12/20/2017
    Part 2 of 5
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source) NDC:0498-0143
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/18/2018
    Part 3 of 5
    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 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0733-00 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 part348 12/23/2017
    Part 5 of 5
    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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4228 FIRST AID KIT 
    4228 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4228
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4228-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 16 PACKET 14.4 g
    Part 2 3 POUCH 1.2 mL
    Part 3 6 PACKET 12 
    Part 4 3 POUCH 1.2 mL
    Part 5 3 AMPULE 0.9 mL
    Part 1 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 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 not final part333A 12/20/2017
    Part 2 of 5
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source) NDC:0498-0143
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/18/2018
    Part 3 of 5
    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 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0733-00 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 part348 12/23/2017
    Part 5 of 5
    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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4225 FIRST AID KIT 
    4225 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4225
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4225-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 16 PACKET 14.4 g
    Part 2 3 POUCH 1.2 mL
    Part 3 6 PACKET 12 
    Part 4 3 POUCH 1.2 mL
    Part 5 3 AMPULE 0.9 mL
    Part 1 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 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 not final part333A 12/20/2017
    Part 2 of 5
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source) NDC:0498-0143
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/18/2018
    Part 3 of 5
    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 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0733-00 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 part348 12/23/2017
    Part 5 of 5
    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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4251 FIRST AID KIT 
    4251 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4251
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4251-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 20 PACKET 18 g
    Part 2 3 POUCH 1.2 mL
    Part 3 6 PACKET 12 
    Part 4 1 POUCH 0.4 mL
    Part 5 3 AMPULE 0.9 mL
    Part 1 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 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 not final part333A 12/20/2017
    Part 2 of 5
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source) NDC:0498-0143
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/18/2018
    Part 3 of 5
    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 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0733-00 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 part348 12/23/2017
    Part 5 of 5
    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
    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(0498-4225, 0498-4227, 0498-4228, 0498-4251)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 manufacture(0498-0114)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(0498-0903)
    Establishment
    Name Address ID/FEI Business Operations
    Changzhou Maokang Medical 421317073 manufacture(0498-0143)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America Inc 874965262 manufacture(0498-0733)
    Close