Label: FRUIT OF THE EARTH HONEYSUCKLE SCENTED ANTIBACTERIAL HAND WITH CANADIAN WILLOWHERB- benzethonium chloride soap

  • NDC Code(s): 62217-087-87
  • Packager: FRUIT OF THE EARTH, INC.
  • 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 October 28, 2021

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    helps reduce bacteria on hands

  • Warnings

    For external use only

  • Do not use

    on infants under 6 months of age

  • When using this product

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

  • Stop use and ask a doctor if

    irritation occurs.

  • Keep out of reach of chlidren

    except under adult supervision. If swallowed, get medical help or contract a Poison Control right away.

  • Directions

    wash hands and rinse

  • Inactive ingredients

    Water, Decyl Glucoside, Glycerin, Cocamidopropyl Betaine, PEG-120 Methyl Glucose Dioleate, Fragrance, Phenoxyethanol, Citric Acid, Epilobium Angustifolium Flower/Leaf/Stem Extract, Tetrasodium EDTA, Alcohol.

  • PRINCIPAL DISPLAY PANEL

    47296E

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH HONEYSUCKLE SCENTED ANTIBACTERIAL HAND WITH CANADIAN WILLOWHERB 
    benzethonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-087
    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
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALCOHOL (UNII: 3K9958V90M)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-087-87237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/12/2021
    Labeler - FRUIT OF THE EARTH, INC. (079559467)
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