Label: MOUSSE NON-RINSE HAND SANITIZER(FRAGRANCE FREE / GRAPEFRUIT)- benzalkonium chloride gel

  • 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 January 9, 2018

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  • Active Ingredient

    BENZALKONIUM CHLORIDE 0.1%

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help decrease bacteria on the skin.

    when water,soap &towel are note available.

    recommended for repeated use.

  • Warning

    For external use only

    Flammable

    Keep away from fire or flame

    Do not apply around eyes,do not use in ears&mouth.

    when using this product,avoid contact with eyes,

    In case of contact flush eyes with water

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hour

    Keep out of reach of children ,children must be supervised in use of this product.

  • Directions

    pump as needed into your palms and thoroughly spread on both hands,rub into skin until dry.

  • INACTIVE INGREDIENT

    Water,Glycerin,Aloe Barbadensis Leaf Juice, Carbomer,Fragrance,Triethanolamine,Tocopheryl Acetate,

  • PRINCIPAL DISPLAY PANEL

    111

  • INGREDIENTS AND APPEARANCE
    MOUSSE NON-RINSE HAND SANITIZER(FRAGRANCE FREE / GRAPEFRUIT) 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61312-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61312-011-028 in 1 CARTON10/23/2016
    1250 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:61312-011-0136 in 1 CARTON10/23/2016
    250 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/11/2016
    Labeler - Hangzhou Guoguang Touring Commodity Co., Ltd. (526890634)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Guoguang Touring Commodity Co., Ltd.526890634manufacture(61312-011)
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