Label: ADVANCED HAND SANITIZER- 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 26, 2020

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  • Drug Facts

  • Active ingredient[s]

    Isopropyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use[s]

    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. Flammable. Keep away from heat or flame.

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    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.

    Keep out of reach of children.

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

  • 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

    glycerin, hydrogen peroxide, purified water USP

  • Company Information

    YUGEN PHARMACEUTICALS

    122 W 27th Street, 11th Floor

    New York, NY 10001

  • Product Packaging - 250 mL

    Yugen PHARMACEUTICALS

    ADVANCED

    HAND SANITIZER

    ALCOHOL 70% GEL FORMULA

    Helps Kill Germs

    Moisturizing

    Unscented

    MADE IN U.S.A.

    USP GRADE

    8.5 FL OZ / 250 ML

    yugen

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79987-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79987-201-10250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    2NDC:79987-201-07946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    3NDC:79987-201-081892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    4NDC:79987-201-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    5NDC:79987-201-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    6NDC:79987-201-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    7NDC:79987-201-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    8NDC:79987-201-05237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    9NDC:79987-201-06500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    10NDC:79987-201-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/26/2020
    Labeler - YUGEN PHARMACEUTICALS, LLC (035620952)
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