Label: BODY RAVES ANTIBACTERIAL HAND SANITIZER - WILD STRAWBERRY- ethyl 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 June 23, 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

    Flammable

    Keep away from heat and flame.

    When using this product

    Avoid contact with face, eyes and broken skin.

     In case of eye contact, flush with plenty of water and seek medical advice.


  • SPL UNCLASSIFIED SECTION

    PEEL UP TO SEE MORE INFORMATON

  • STOP USE

    Stop use and ask a doctor if:

      irritation or redness develops.

    Keep out of reach of children.

    If swallowed get medical help or contact a poison control center.


  • 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, DMDM Hydantoin, Hydrogenated Jojoba Oil, FD and C Red No 33, FD and C Red No. 40



    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

    3.1 Fl oz/90 ml

  • PRINCIPAL DISPLAY PANEL

    handsanbacklabel

  • PRINCIPAL DISPLAY PANEL

    BODY RAVES
    ANTIBACTERIAL
    HAND SANITIZER
    LAVENDER VANILLA

    3.1 FL OZ / 90 ML
  • PRINCIPAL DISPLAY PANEL

    handsanitizerfront

  • INGREDIENTS AND APPEARANCE
    BODY RAVES ANTIBACTERIAL HAND SANITIZER - WILD STRAWBERRY 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-154
    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)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-154-0390 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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