Label: ANTIBACTERIAL HANDWASH HOBBY- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 29, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • USES

    • For Handwashing to decrease bacteria on the skin
  • WARNING

    For external use only.

  • WHEN USING

    • avoid contact with eyes.
    • If  contact occurs, rinse thoroughly with water.
  • Stop use and ask a doctor if

    • If irritation occurs.
  • KEEP OUT OF REACH OF CHILDREN.

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

  • DIRECTIONS

    • Rub thoroughly into wet hands for at least 15 seconds.
    • Rinse and dry children should be supervised by an adult when using this product.
  • Inactive Ingredients:

    Water（Aqua),Cocamidopropyl Betaine, Coco-glucoside,Sodium Chloride,Fragrance, Citric Acid,Methylchloroisothiazolinone,Methylisothiazolinone,D&C Red No.33,FD&C Yellow No.6, FD&C Yellow No. 5,PEG-150 distearate,Cocamide/MEA,Benzophenone-4,Parfum,Tetrasodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    SOAP1SOAP2

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HANDWASH  HOBBY
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71611-042-01400 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    2NDC:71611-042-022000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/29/2020
    Labeler - Click Products LLC (080766174)
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