Label: INSTANT HAND SANITIZER EXTRA ENRICHED WITH VITAMIN E BEAD STRAWBERRY SCENT- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 10, 2012

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  • ACTIVE INGREDIENT


    Active Ingredient                                   Purpose

    Alcohol         62%             **********        Antiseptic
  • PURPOSE



    Hand sanitizer to help decrease bacteria on the skin. when water, soap and towel are not available.

    Recommended for repeat use
  • KEEP OUT OF REACH OF CHILDREN

    Children must be supervised in use of this product.

  • INDICATIONS & USAGE


    Pump as needed into your palms and thoroughly spread on both hands.
    Rub into skin until dry.

  • WARNINGS


    For external use only.
    Flammable, keep away from fire or flame.
    Do not apply around eyes; Do not use in ears and mouth.
    When using this products, 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 hours.

    Store at 20°C (68° to 77°F), may discolor fabrics.

  • DOSAGE & ADMINISTRATION

    Pump as needed into your palms and thoroughly spread on both hands.
    Rub into skin until dry.

  • INACTIVE INGREDIENT

    Water, Triethanolamine, Glycerin, Propylene glycol, Tocopheryl acetate, aloe, Barbadensis, Carbomer, Fragrance, Red 33
  • PRINCIPAL DISPLAY PANEL

    image of bottle label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER EXTRA ENRICHED WITH VITAMIN E BEAD STRAWBERRY SCENT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1401-12 in 1 BOX
    159.2 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E05/10/2012
    Labeler - Greenbrier International (610322518)
    Registrant - Ningbo Pulisi Daily Chemical Products Co., (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co.,529047265manufacture