Label: FORTADERM ANTISEPTIC HAND SANITIZER- alcohol gel

  • NDC Code(s): 78209-000-01
  • Packager: Forta Lab, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70%

    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.

  • Other information

    • Store in a cool, dry place at room temperature not above 86° F (30° C).
    • Do not leave exposed to the rays of the sun.
  • Inactive ingredients

    Water, glycerin, carbomer, triethanolamine.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    FORTADERM ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78209-000
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78209-000-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/01/2020
    Labeler - Forta Lab, S.A. de C.V. (812869717)
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