Label: ANTISEPTIC HAND SANITIZER FOAM- ethyl alcohol liquid

  • 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 June 15, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl alcohol 62% v/v

  • Purpose

    Antibacterial Agent

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • Warnings

    Flammable, keep away from fire or flame. For external use only.

    Avoid contact with eyes. In case of contact, flush with plenty of water.

    Stop use and ask a doctor if irritation or rash appears and persists.

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

    EMERGENCY TELEPHONE: 1-866-923-4913

  • Directions

    • Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.

    • Children under 6 years of age should be supervised when using this product.

  • Other Information

    • Store in a cool, dry place.

  • Inactive Ingredient

    • Water, Glycerin, PEG-10 Dimethicone

  • SPL UNCLASSIFIED SECTION

    Providing Exceptional Quality Since 1962

    Distributed by/Distribuido por:

    U S Chemical

    316 Hart Street · Watertown, WI 53094

    www.uschemical.com

    Emergency Phone 1-866-923-4913

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER FOAM 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61307-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61307-105-103790 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/10/2020
    Labeler - US Chemical Corporation (031457842)
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