Label: BODY LUXURIES WATERLESS HAND SANITIZER- ethyl alcolhol 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 June 21, 2010

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  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredients                        Purpose

    Ethyl Alcohol 62%                        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.

    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

  • SPL UNCLASSIFIED SECTION

    PEEL UP TO SEE MORE INFORMATON

  • STOP USE

    Stop use and ask a doctor if skin irritation develops.

    Keep out of 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.

  • INFORMATION FOR PATIENTS

    Other information

    Do not store above 105 degrees F

    May discolor some fabrics

    Harmful to wood finishes and plastics.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Ingredients/Ingredients: Alcohol, Water (aqua), Glycerin

    Triethanolamine, Carbomer, PEG-40 Hydrogenated Castor Oil

  • PRINCIPAL DISPLAY PANEL

    handsanbacklabel

  • PRINCIPAL DISPLAY PANEL

    BODY LUXURIES

    WATERLESS HAND SANITIZERS

    0.17 FL OZ/5ML

  • PRINCIPAL DISPLAY PANEL

    handsanitizerfront

  • INGREDIENTS AND APPEARANCE
    BODY LUXURIES WATERLESS HAND SANITIZER 
    ethyl alcolhol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-153
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-153-175 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33306/21/2010
    Labeler - Enchante Accessories (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Blue Dream Cosmetic Co., Ltd.529047234manufacture
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