4164 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC.]

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4164 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC.]
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NDC 0498-0501-00, 0498-3334-00, 0498-4164-01
Set ID 88055371-ca11-6d17-e053-2a95a90ad23a
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • 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)
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