Label: YELLOWHAMMER BREWING HAND SANITIZER- ethanol 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 March 23, 2020

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  • ACTIVE INGREDIENT

    Alcohol 80%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame.

  • DO NOT USE

    Do not use:

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • OTHER SAFETY INFORMATION

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • INACTIVE INGREDIENT

    glycerin, hydrogen peroxide, purified water USP

  • PRINCIPAL DISPLAY PANEL

    a

  • INGREDIENTS AND APPEARANCE
    YELLOWHAMMER BREWING HAND SANITIZER 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74000-819
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74000-819-320.946353 L in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    2NDC:74000-819-013.78541 L in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    3NDC:74000-819-259.46353 L in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    4NDC:74000-819-0518.9271 L in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    5NDC:74000-819-040.118294 L in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    6NDC:74000-819-080.236588 L in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    7NDC:74000-819-120.354882 L in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    8NDC:74000-819-330.1 L in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    9NDC:74000-819-160.05 L in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/25/2020
    Labeler - Yellowhammer Brewing, Inc. (054796794)
    Registrant - Yellowhammer Brewing, Inc. (054796794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yellowhammer Brewing, Inc.054796794manufacture(74000-819)
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