Label: 4164 FIRST AID KIT kit

  • NDC Code(s): 0498-0501-00, 0498-3334-00, 0498-4164-01
  • 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 May 3, 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 (59 0 - 86 0 F)
    • do not reuse towelette
  • BZK Inactive ingredient

    water

  • BZK Questions

    1-800-430-5490

  • 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
    i

    f 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.
  • Ammoniia 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

  • 4164 SF00004064 Kit contents

    1 AMMONIA INHALANTS 10 PER

    4 GAUZE BANDAGE, 4" X 6 YD

    5 TRIANGULAR BDG, NON-STERILE

    2 WIRE SPLINT 1 PER

    1 ADHESIVE TPE 1"X2-1/2 YD 2 PER

    8 BANDAGE COMP, 4" OFFSET, 1 PER

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

    1 NITRILE GLOVES 2PR BBP

    2 ANTIMCRBL ANTSPTC TWLETTS

    1 SCISSOR BDGE 4" RED PLS HDL

    LBL STOCK 6-3/8"X4"

    1 LBL STOCK 3"x1-7/8"

    3 PAD LOCK PLASTIC SEAL

    2 WATER-JEL BURN DRESSING 4 X 4

    1 WATER-JEL BURN DRESSING 2 X 6

    4 LABEL "FIRST AID" EACH SIDE

    1 EXPIRATION STICKER NP31TH

    1 LABEL ON INSIDE LID CTY1872-5

    1 SERVICE RECORD PLACARD ATY1160

    1 KIT PP 24 UNIT FA

  • BZK Principal Display Panel

    Antiseptic Wipe

  • Ammonia Principal Display Panel

    Ammonia Inhalant

  • 4164 Kit Label SF00004064

    4164 label

  • INGREDIENTS AND APPEARANCE
    4164 FIRST AID KIT 
    4164 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4164
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4164-011 in 1 KIT10/13/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 AMPULE 3 mL
    Part 22 PACKET 2.8 mL
    Part 1 of 2
    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 2 of 2
    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 finalpart333E12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/13/2018
    Labeler - Honeywell Safety Products USA, Inc. (079287321)
    Registrant - Honeywell Safety Products US, Inc. (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander040756421manufacture(0498-3334)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety products USA, Inc.079287321pack(0498-4164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0501)