Label: ANTISEPTIC SANITIZING- 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 May 18, 2021

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  • DRUG FACTS

  • Active ingredient

    Ethyl alcohol 70%

    Purpose

    Antiseptic

  • Use

    For hands washing to decrease bacteria

  • 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.

  • Dierctions

    Spray thoroughly and allow to dry with wiping

  • Other information

    • Keep the container tightly closed
  • Inactive ingredients

    Lemon Fragrance
    Thyme Fragrance
    Triethanolamine
    Water

  • Questions or comments?

    888-338-8111

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SANITIZING 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80365-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80365-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2021
    Labeler - Adam br srl (440929232)
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