Label: HAND SANITIZER- 65% 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 May 21, 2020

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  • Active Ingredient(s)

    Alcohol 65% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep product away from open flames.

    For external use only.

  • Do not use

    Do not use on children less than 2 months of age.

    Do not use on open skin wounds.

  • WHEN USING

    When using this product, avoid contact with eyes and broken skin.

    In case of contact with eyes, rinse immediately with water.

  • STOP USE

    If skin irritation occurs, discontinue use. Consult a doctor if rash persit.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and superise during use.

  • Directions

    Rua hands throughly with gel and let dry.

  • Other information

    Do not strore above 110℉/43℃.

  • Inactive ingredients

    Water, VE.

  • Package Label - Principal Display Panel

    60

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    65% alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69980-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL39 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69980-101-0360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - Shandong Vianor Healthy Science Co., Ltd. (554532204)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Vianor Healthy Science Co., Ltd.554532204label(69980-101) , manufacture(69980-101)
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