Label: 4378 FIRST AID KIT kit

  • NDC Code(s): 0498-0501-00, 0498-2110-01, 0498-4378-01
  • 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 June 9, 2019

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

  • BZK Active ingredient

    Benzalkonium chloride 0.13% w/v

  • BZK Purpose

    First aid antiseptic

  • BZK Uses


    Antiseptic cleansing of face, hands, and body without soap and water

  • BZK 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

  • BZK Directions


    tear open packet and use as a washcloth

  • BZK Other information

    • store at room temperature 15 0 to 30 0 C (5 0 - 86 0 F)
    • do not reuse towelette
  • BZK Inactiave ingredient

    water

  • BzK Questions

    1-800-430-5490

  • Aypanal Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Aypanal Purpose

    Pain reliever/fever reducer

  • Aypanal 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.
    • 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 skin reaction 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 use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    If pregnant or breastfeeding

    • ask a health professional before use.

    Keep out of reach of children.

    Keep out of reach of children.

    Overdose warning: In case ofl 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.

  • Aypanal Directions

    • do not take more than directed (see overdose warning)
    • adults and children 12 years of age and over: Take 2 tablets with water every 6 hours while symptoms last.
    • do not take any more than 8 tablets in 24 hours.
    • children under 12: consult a doctor
  • Aypanal Other information

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

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

  • Aypanal Questions or Comments

    1-800-430-5490

  • FABC Active ingredient

    Benzalkonium chloride 0.13%

    Lidocaine HCl 0.5%

  • FABC Purpose

    First Aid antiseptic

    External analgesic

  • FABC Uses

    • prevent skin infection
    • for temporary relief of pain associated with minor burns
  • FABC Warnings

    For external use only

    Do not use

    • in or near the eyes
    • if you are allergic to any of the ingredients
    • lin 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

    Keep out of reach of children

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

  • FABC 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
  • FABC 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

  • FABC Questions

    1-800-430-5490

  • Sting Relief Active ingredient (in eachwipe)

    Ethyl alcohol 50.0%

    Lidocaine HCl 2.0%

  • Sting Relief Purpose

    Antiseptic

    Topical pain relief

  • Sting Rellief Uses

    • prevent infection in minor scrapes, and temporary relief of itching of insect bites
  • 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.

  • 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.
  • Sting Relief Inactive ingredients

    benzalkonium chloride, menthol, and purified water

  • Sting Relief Questions or Comments?

    1-800-430-5490

  • 4378 Z631580000 KIT CONTENTS

    1 INSTANT COLD PACK 4" X 6"

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

    1 TWEEZER PLASTICS 4"

    1 FIRST AID GUIDE ASHI

    1 ABD COMBINE PAD 5" X 9"

    1 CPR FILTERSHIELD 77-100

    1 FIRST AID BURN CREAM 0.9 GRM PKT 20

    1 SCISSOR BDGE 4" RED PLS HDL

    1 FANNY PACK RED FAK LOGO EMPTY

    1 LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    6 BZK ANTISEPTIC WIPE, BULK

    1 1 PR LRG NITRILE GLVES ZIP BAG

    1 1" X 3" PLASTIC BANDS 16/BAG

    5 SAFETEC STING RELIEF WIPES BULK

    1 TRI BNDG NON WOVEN 40"X40"X56"

    3 GAUZE PADS 3"X3" 12PLY

    2 HEAVY FLEX LARGE PATCH 2" X 3"

    2 AYPANAL EXTRA BULK 2/PK

  • BZK Principal Display Panel

    Antiseptic Wipe

  • Aypanal Principal Display Panel

    aypanalex label

  • FABC Principal Display Panel

    First Aid Burn Cream

  • Sting Relief Principal Display Panel

    Sting Relief

  • 4378 Kit Label Z631580000

    4378 label

  • INGREDIENTS AND APPEARANCE
    4378 FIRST AID KIT 
    4378 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4378
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4378-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 15 POUCH 2 mL
    Part 26 PACKET 8.4 mL
    Part 32 PACKET
    Part 420 PACKET 18 g
    Part 1 of 4
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source)NDC:0498-0733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2017
    Part 2 of 4
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/22/2017
    Part 3 of 4
    AYPANAL EX 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:0498-2110
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2110-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/02/2017
    Part 4 of 4
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2018
    Labeler - Honeywell Safety Products USA, INC (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, INC079287321pack(0498-4378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(0498-2110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0903)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America Inc874965262manufacture(0498-0733)