Label: 75% ALCOHOL INSTANT HAND SANITIZER spray

  • 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 28, 2020

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  • Active Ingredient(s)

    75% Ethyl alcohol

  • Purpose

    Kills more than 99.9% of germs; waterless gel

  • Use

    Put a dime-size amount in your palm and briskly rub your hands until dry

  • Warnings

    For external use only. Flammable. Keep away from

    heat or flame

  • Do not use

    1, In children less than 2 months of age.
    2, On open skin wounds.

  • WHEN USING

    1, When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    2, Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    3, 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

    1, Place enough product on hands to cover all surfaces. Rub hands together until dry.
    2, 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

    purified water

  • Package Label - Principal Display Panel

    10025050

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL INSTANT HAND SANITIZER 
    75% alcohol instant hand sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78412-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78412-006-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:78412-006-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:78412-006-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Ganzhou Hongda Biochemical and Industrial Chemical Co., Ltd (554534260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Hongda Biochemical and Industrial Chemical Co., Ltd554534260manufacture(78412-006)
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