Label: ANTISEPTIC 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 March 27, 2011

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  • ACTIVE INGREDIENT


    Active Ingredient

    Ethyl Alcohol 62%
  • PURPOSE


    Purpose

    Antiseptic

  • WARNINGS

    Warnings: Flammable, keep away from fire or flame. For external use only on hands.

    When using this product: 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.

    Keep out of reach of children: If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Spread on both hands, rub in, let dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe barbadensis gel, carbomer, fragrance, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water.

  • QUESTIONS

    Manufactured in China for Innovation Specialties, Culver City, CA 90230 -Questions? Call 1-855-755-5346 - Lot #

  • PRINCIPAL DISPLAY PANEL

    Bottle1

  • INDICATIONS & USAGE

    Uses: For handwashing to decrease bacteria on the skin.

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL36.58 mL  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76138-001-0159 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/27/2011
    Labeler - Innovation Specialties (030837314)
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