Label: GTM GEL- isopropyl 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 August 10, 2020

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  • DRUG FACTS

  • Active Ingredient

    Isopropyl Alcohol 70%

    Purpose

    Antimicrobial

  • Use

    To decrease bacteria on surfaces or on the skin. For use when soap and water are not available.

  • WARNINGS

    Flammable. Keep away from fire or flame. For external use only

    When using this product

    • Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor 

    • If irritation or rash appears.

    Keep out of reach of children 

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

  • Directions

    • Place enough product on the Surface with a towel or hands and rub briskly until dry. Children under 6 years of age should be supervised when using this product

  • Other information

    • Store below 86°F (30°C). May discolor certain fabrics or surfaces. Harmful to Wood finishes and plastics.

  • Inactive Ingredients 

    • Water, Tylose, Glycerin.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    GTM GEL 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79859-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TYLOSEMA ESCULENTUM WHOLE (UNII: 5M1OL152FO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79859-001-003785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - GTM Costa Rica Sociedad Anonima (853075281)
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