Label: ANTI-BACTERIAL HAND GEL- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 26, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Ethyl Alcohol 62%

  • PURPOSE

    Purpose Antiseptic

  • WARNINGS

    Warnings: For external use only. Flammable. Keep away from fire or flame. Do not apply around eyes. Do not use in ears or mouth. When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

  • STOP USE

    Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • DOSAGE & ADMINISTRATION

    Directions: Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Aloe Barbadenis Leaf, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, FD&C Blue No.1

  • INDICATIONS & USAGE

    Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use

  • Other information

    Do not store in temperature over 118 F.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL HAND GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70483-001
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70483-001-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/25/2016
    Labeler - Jean Pierre Inc. (138328393)
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