Label: SANIHOO GEL HAND SANITIZER- gel hand sanitizer 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 July 8, 2020

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  • Active Ingredient(s)

    Alcohol 69% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to held 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

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


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


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

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together to dry.

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP, carbomer, PEG-200, denatonium benzoate, triethanolamine

  • Package Label - Principal Display Panel

    1040987.75 Sani-Hoo 275 Gal Gel mL NDC: 78888-380-27

  • INGREDIENTS AND APPEARANCE
    SANIHOO GEL HAND SANITIZER 
    gel hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78888-380
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.5 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 24.75 mL  in 100 mL
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 2 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.09 mL  in 100 mL
    CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5) 0.5 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78888-380-271040987.75 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/26/2020
    Labeler - Red Barn Brands, LLC (087153900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Red Barn Brands, LLC087153900manufacture(78888-380)
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