Label: 80 ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER- alcohol 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 10, 2022

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 80%

    Purpose

    Antiseptic

  • Use

    for hand washing to decrease bacteria on the skin

  • Warnings

    For external use only

    Flammable, keep away from fire or flame.

    Do not use

    in the eyes

    Stop use and ask a doctor if

    • Irritation and redness develop
    • Condition persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    wet hands thoroughly with product and allow to dry without wiping.

  • Inactive ingredients

    Hydrogen peroxide, glycerin, FD&C Blue No. 1, fragrance

  • Questions? :

    +1-716-430-3572

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    80 ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82444-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82444-001-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/30/2022
    Labeler - SCHEVARAN LABORATORIES PRIVATE LIMITED (650656770)
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