Label: 70% ADVANCED ALCOHOL GEL SANITIZER IV- ethyl 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

    Ethyl alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Uses

    Hand sanitizer to reduce microorganisms on the skin.
    Use this product when soap and water are not available.

  • Warnings

    For external use only.
    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition.
    • Discontinue use if irritation or redness develops. • If irritation persists for more than 72 hours,
    consult a physician. • KEEP OUT OF REACH OF CHILDREN.
    • If swallowed, get medical help or contact a Poison Control Center right away.

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

  • Directions

    Read the entire label before using this product.

    Place enough product on your palm to thoroughly cover your hands.
    Rub hands together briskly for 30 seconds until dry.

  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    Purified Water, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Glycerin, Fragrance (Parfum).

  • Questions?

    888-GO BETCO (888-462-3826)

  • Packaging

    721E9-00

  • INGREDIENTS AND APPEARANCE
    70% ADVANCED ALCOHOL GEL SANITIZER IV 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-100
    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)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-100-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/19/2020
    Labeler - Betco Corporation, LTD (024492831)
    Registrant - RealChem Manufacturing Inc (117584702)
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