Label: ANTISEPTIC HAND SANITIZER ETHYL ALCOHOL- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 August 5, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% Purpose:Antiseptic

  • Purpose

    Antiseptic

  • Uses

    • For handwashing 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
  • Other information

    • Store below 106ºF (41ºC). May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Isopropyl alcohol, Carbomer, and Triethanolamine.

  • Questions or comments?

    +1 (305)517-7739

  • PRINCIPAL DISPLAY PANEL

    500 ML NDC:79036-000-02

    500 ml label

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER ETHYL ALCOHOL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79036-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79036-000-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    2NDC:79036-000-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2020
    Labeler - Corporacion Saint Germain (816054674)
    Registrant - Corporacion Saint Germain (816054674)
    Establishment
    NameAddressID/FEIBusiness Operations
    Corporacion Saint Germain816054674manufacture(79036-000)
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