Label: FIRSTHAND ADVANTAGE PREMIUM 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 May 14, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • Active Ingredients:

    Ethyl Alcohol 70%

  • Purpose

    Antibacterial

  • USE:

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS:

    For external use only

    Keep out of reach of Children

    If swallowed, get medical help or contact a poison control center immediately

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • DIRECTIONS:

    Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.

  • OTHER INFORMATION:

    Store between 15- 30C (59- 86F) • Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENTS:

    Water, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Glycerin, Tocopheryl Acetate (Vitamin E), Acrylates/C10-30 Alkyl Acrylate Crosspolmer, Aminomethyl Propanol.

  • Principal Display Panel – 1 Gallon Bottle Label

    AGE ADVANTAGE®

    SKIN CARE

    FIRST HAND
    ADVANTAGE

    Kills 99.9%
    of Germs

    PREMIUM
    SANITIZER

    moisturizing formula with aloe

    ONE GALLON

    Principal Display Panel – 1 Gallon Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIRSTHAND ADVANTAGE PREMIUM SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79215-101
    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)  
    Butyl Acrylate/Methyl Methacrylate/Methacrylic Acid Copolymer (18000 MW) (UNII: JZ1374NL9E)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Glycerin (UNII: PDC6A3C0OX)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79215-101-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    2NDC:79215-101-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    3NDC:79215-101-993785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/07/2020
    Labeler - Age Advantage Brands LLC (088956468)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fresh & Beautiful Cosmetics117409349MANUFACTURE(79215-101)
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