Label: BODY LUXURIES VANILLA FROSTING ANTIBACTERIAL HAND SANITIZER- alcohol liquid

  • 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 January 20, 2011

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  • SPL UNCLASSIFIED SECTION

    Antibacterial Hand Sanitizer

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Ethyl Alcohol 62%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • To decrease bacteria on the skin that could cause disease.
    • Recommended for repeated use.

  • WARNINGS

    Warnings

    For external use only.

    Flammable. Keep away from heat and flame.

    When using this product

    • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • Avoid contact with broken skin.
    • Do not inhale or ingest.

    Stop use and ask a doctor if skin irritation develops.

    Keep out reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.
  • STORAGE AND HANDLING

    Other Information

    • Do not store above 105 degrees F
    • May discolor some fabrics.
    • Harmful to wood finishes and plastics.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water (Aqua), Glycerin, Triethanolamine, Carbomer, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil,  FD and C Red No.40, FD and C Yellow 5, FD and C Blue No.1

  • SPL UNCLASSIFIED SECTION

    Formulated Exclusively and Distributed By:

    Enchante Accessories, Inc.,

    New York, NYm 10016

    Not Tested On Animals, For Adult Use Only.

    Designed in the USA. Made in China

    3 FL. OZ / 90ML



  • PRINCIPAL DISPLAY PANEL

    body luxuries

    Vanilla Frosting

    Antibacterial Hand Sanitizer

    3.1 FL. OZ / 90ML



    Vanilla

  • INGREDIENTS AND APPEARANCE
    BODY LUXURIES VANILLA FROSTING ANTIBACTERIAL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    JOJOBA OIL (UNII: 724GKU717M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-500-0190 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E01/20/2010
    Labeler - Enchante Accessories, Inc. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Blue Dream Cosmetics Co., Ltd.529047234manufacture
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