Label: HAND SANITIZER- 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 October 10, 2020

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  • Uses

    Uses

    * Helps eliminated bacterias on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

  • Active Ingredient

    Active Ingredient Purpose

    • Ethyl Alcohol 70%...................................Antiseptic
  • Warnings

    • For external use only
    • When using this product avoid contact with eyes. In case of contact, flush with water for several minutes.
    • Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
    • Stop use and ask Doctor: if skin irritation develops when using this product
    • Flammable: Keep away from heat and flame. Highly flammable liquid and vapor/

  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    * Irritation develops while using this product

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

  • Directions

    Directions: Place enough product in your palm to throughly cover your hands.

    • Rubs hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product
  • Inactive Ingredients

    water, carbomer, propylene glycol, triethanolamine

  • Questions?

    QUESTIONS OR COMMENTS: Phone: (786) 871-6663

  • Uses

    Uses

    * Helps eliminated bacteria on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

  • Hand Sanitizer Gel

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78167-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78167-008-017570.82 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2020
    Labeler - Transformaciones Del Caribe, Sociedad Anonima (817531659)
    Registrant - Transformaciones Del Caribe, Sociedad Anonima (817531659)
    Establishment
    NameAddressID/FEIBusiness Operations
    Transformaciones Del Caribe, Sociedad Anonima817531659manufacture(78167-008)
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