Label: HYGIENE CLEAN BALSAM FIR HAND SANITIZER ALCOHOL FREE- benzalkonium chloride liquid

  • NDC Code(s): 80499-004-01, 80499-004-02
  • Packager: USA Broom LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2023

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antimicrobial

  • Uses

    - For hand sanitizing to decrease the bacteria on skin.

    - Recommended for repeated use.

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor 

    if irritation or redness develops, or if condition persists for more than 72 hours.

    KEEP OUT OF REACH OF CHILDREN.

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

  • DIRECTIONS

    - Pump a small amount of foam into palm of hand

    - Rub thoroughly over all surfaces of both hands

    - Rub hands together briskly until dry

  • Inactive ingredients:

    Water; Propylene Glycol; Lauramine Oxide, Undeceth-7; Disodium EDTA; Aloe Barbadensis Gel; Glycereth-2-Cocoate; DMDM Hydantoin; Fragrance, Citric Acid

  • Package Labeling:(237 ml)

    Label

  • Package Labeling:(237 ml)- 24 bottles

    Label2

  • INGREDIENTS AND APPEARANCE
    HYGIENE CLEAN BALSAM FIR HAND SANITIZER ALCOHOL FREE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80499-004
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    UNDECETH-7 (UNII: R6B5PCO2JN)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80499-004-01237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2020
    2NDC:80499-004-0224 in 1 BOX09/30/2020
    2237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/30/2020
    Labeler - USA Broom LLC (117638854)
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