Label: FARMACY ANTISEPTIC 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 April 20, 2020

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  • Drug Facts

  • Active Ingredients

    Ethanol 70% v/v

    Purpose

    Antiseptic

  • Uses

    Hand Santizer to help reduce bacteria on the skin only when water and soap is not availabel.

  • Warnings

    For external use only. Flammable. Keep away from heat and Flame.

    When using this product

    • keep out of eyes, ears and mouth.
    • if contact occurs, rinse eyes thorughly with water.

    Stop use and ask a doctor

    • if irritation and rash occurs.

    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 rub hands together until dry.
    • Supervise children under 6 years of age when using. 
  • Inactive Ingredients

    Water, Glycerin, Carbomer, Dipropylene Glycol, Isopropyl Myristate, Triethanolamine, Citrus Paradisi (Grapefruit) Seed Extract, Aloe Barbadensis Leaf Juice Powder

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    FARMACY ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72830-001
    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)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72830-001-6060 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 not finalpart333E06/01/2020
    Labeler - Farmacy Beauty LLC (081343430)
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