Label: HOME FORMATION ANTIBACTERIAL SHEA BUTTER- 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 February 10, 2021

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  • Active ingredient

    Benzalkonium Chloride (0.13%)

  • Purpose

    Antibacterial

  • Warnings

    For external use only.
    When using this product avoid contact with eyes . In case of eyes contact, flush with water.

    Stop use and ask a doctor if irritation and redness develops.

    Keep out of reach of children if swallowed, get medical help or contact a Poison control center right away.

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Directions

    • Pump into hands.
    • Lather vigorously for at least 15 seconds.
    • Rinse and dry thoroughly.

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive ingredient

    Water, Sodium Laureth Sulphate,Sodium Laureth sulfate & Glycol Distearate & Cocamide MEA & Laureth - 10, Cocamido Propyl Betaine,
    Cocomonoethanolamide, Sodium Chloride, Glycerine,Perfume, PEG 150 Distearate, Bronopol, Disodium EDTA,Phenoxyethanol, Benzophenone 3, Citric Acid, CI. No. 17200,  FD and C Yellow 5,CI. No. 19140 , D and C Red 33.

  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    HOME FORMATION ANTIBACTERIAL SHEA BUTTER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68121-005
    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
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    LAURETH-10 (UNII: BD7AST04GA)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68121-005-01333 mL in 1 BOTTLE; Type 0: Not a Combination Product02/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/03/2021
    Labeler - PATCOS COSMETICS (INDIA) PRIVATE LIMITED (916169451)
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