Label: HEALING WATERS CUCUMBER MELON SCENTED WATERLESS HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 June 2, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients

    Ethyl Alcohol 62 percent

    Purpose

    Antiseptic

  • PURPOSE

    Uses

    To decrease bacteria on the skin that could cause disease.

    Recommended for repeated use.

  • WARNINGS

    Warnings

    For external use only-hands

    Flammable, Keep away from heat and flame.

  • INDICATIONS & USAGE

    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 fahrenheit.

    May discolor some fabrics.

    Harmful to wood finishes and plastics.


  • INACTIVE INGREDIENT

    Inactive Ingredients

    Ingredients: Alcohol, Water (Aqua), Triethanolamine, Carbomer, Fragrance (Parfum), PEG 40 Hydrogenated Castor Oil,

    DMDM Hydatoin, Hydrogenated Joboja Oil,  FD and C Red No. 33, FD and C Red No. 40.

  • DESCRIPTION

    Formulated Exclusively and Distributed By:

    Enchante Accessories, Inc.,

    New York, NY 10016

    Not Tested On Animals. For Adult Use Only.

    Designed in the USA. Made in China.
  • PRINCIPAL DISPLAY PANEL

    Healing Waters

    Cucumber Melon

    Scented

    Waterless

    Hand Sanitizer

    8 FL. OZ 236 ML

  • PRINCIPAL DISPLAY PANEL

    melonsan
  • PRINCIPAL DISPLAY PANEL

    cucumbermelon

  • INGREDIENTS AND APPEARANCE
    HEALING WATERS CUCUMBER MELON SCENTED WATERLESS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-151
    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
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-151-08236 mL in 1 BOTTLE
    2NDC:50563-151-0390 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33302/22/2010
    Labeler - Enchante Accessories, Inc (186050696)
    Registrant - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Blue Dream Cosmetics Co., Ltd. 529047234manufacture
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