Label: INSTANT HAND SANITIZER- 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 June 19, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    • For external use only. Keep out of reach of children.
    • Flammable. Keep away from source of heat or fire.
  • Do not use

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

    When using this product avoid contact with eyes. If contact occurs in case, rinse with water.

  • STOP USE

    Stop using this product and ask doctor if irritation or redness develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 

  • Directions

    • Wet hands thoroughly and rub together until dry.
    • Children under 6 years of age should be supervised when using instant hand sanitizer.
  • Other information

    • Seal and store at a temperature below 40C (104F)
  • Inactive ingredients

    glycerin, water, Isopropyl Myristate, Carbomer, Aloe Leaf juice, Tocopheryl Acetate, Aminomethyl propanol, Rose oil.

  • Package Label - Principal Display Panel

    266 mL NDC: 78766-001-01

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  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78766-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70   in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 3   in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.5   in 100 mL
    WATER (UNII: 059QF0KO0R) 25.9   in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.04   in 100 mL
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.05   in 100 mL
    ALOE FEROX LEAF (UNII: 0D145J8EME) 0.1   in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.4   in 100 mL
    ROSE OIL (UNII: WUB68Y35M7) 0.01   in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78766-001-01266 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2020
    2NDC:78766-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/13/2020
    Labeler - Zhejiang Bayside Biotech Co., Ltd. (554477072)
    Registrant - Zhejiang Bayside Biotech Co., Ltd. (554477072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Bayside Biotech Co., Ltd.554477072manufacture(78766-001) , label(78766-001)
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