Label: GERM-AWAY- anti-microbial cloth

  • 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 August 22, 2020

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  • Active Ingredient

    Benzalkonium chloride 01%

  • Purpose

    Anti-bacterial

  • Keep out of the reach of children.

    Keep out of reach of children, except with adult supervision.

  • Inactive Ingredients

    Aqua, Decyl Glucoside, Glycerin, Sodium Hydroxymethylglycinate, Citric Acid, PEG-12 Dimethicone Copolyol, Tetrasodium EDTA, Potassium Sorbate, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Allantoin, Panthenol, Tocopheryl Acetate, Fragrance

  • Warnings

    For external use only. Do not use in the eyes.

    Keep out of eyes. In case of eye contact, rinse with water. If irritation develops, discontinue use. Consult doctor if irritation persists for more than 72 hours.

    If swallowed, seek medical attention or contact a Poison Control Center.

  • Directions

    Pull one sheet from packet.

  • Use

    Sanitize hands or other affected area. Discard in trash after use. Do not flush. Reseal packet after use to retain moisture.

  • PRINCIPAL DISPLAY PANEL

    Germ-Away

  • INGREDIENTS AND APPEARANCE
    GERM-AWAY 
    anti-microbial cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74680-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SANDALORE (UNII: 1XL3NL51UU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    4-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 21EUM2B8UC)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    TETRAHYDROLINALOOL (UNII: UM4XS5M134)  
    2,2'-OXYDIPROPANOL (UNII: 7KOI7K0DHI)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    3,7-DIMETHYL-1-OCTANOL (UNII: DPY9K1927C)  
    COUMARIN (UNII: A4VZ22K1WT)  
    DIPHENYL ETHER (UNII: 3O695R5M1U)  
    CP FORMATE (UNII: CEB8Q6WHK2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74680-106-1750 in 1 JAR; Type 0: Not a Combination Product06/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/11/2020
    Labeler - Unico International Trading Corp (805757200)
    Registrant - Dan Mor (514523067)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dan Mor514523067manufacture(74680-106)
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