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 July 13, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Anti-microbial

  • Use

    • Hand Sanitizer to help reduce bacteria on skin
  • 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 and lasts.

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

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using the product.
  • Other Information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive Ingredients

    Water , Glycerin, Propanediol, Panthenol, Aminomethyl Propanol, Carbomer, Fragrance, Carthamus Tinctorius (Safflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Sodium Hyaluronate, Green 5, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

    precos

    HAND
    SANITIZER
    GEL

    KILLS
    99.9%
    OF GERMS
    & BACTERIA

    WITH ALOE VERA
    & PRO VITAMIN B5
    TO MOISTURIZE

    OCEAN

    3.4 FL OZ / 100mL

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62516-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propanediol (UNII: 5965N8W85T)  
    Panthenol (UNII: WV9CM0O67Z)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Safflower Oil (UNII: 65UEH262IS)  
    Cucumber (UNII: YY7C30VXJT)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62516-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A06/19/2020
    Labeler - Weckerle Cosmetics LLC (152060273)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weckerle Cosmetics LLC152060273LABEL(62516-001) , MANUFACTURE(62516-001)
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