Label: GERMISEPT ANTIBACTERIAL ALCOHOL 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 October 27, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

    Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease.
    • recommended for repeated use.
  • Warnings

    • For external use only. 
    • Flammable.
    • Keep away from heat or flame.

    When using this product

    • keep out of eyes.
    • In case of contact with eyes, flush throughly with water.
    • Avoid contact with broken skin.
    • Do not inhale or ingest.

    Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours.

    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

    • Do not store above 105°F
    • May discolor some fabrics
    • Harmful to wood finishes and plastics.
  • Inactive Ingredients

    Aqua (Water), Glycerin, Acrylates/c10-30 alkyl acrylate crosspolymer, Aminomethyl propanol, Fragrance (Perfume).

  • Package Labeling:1000ml

    Label

  • Package Labeling:3800ml

    Bottle2

  • INGREDIENTS AND APPEARANCE
    GERMISEPT ANTIBACTERIAL ALCOHOL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80862-000
    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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80862-000-011000 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2020
    2NDC:80862-000-023800 mL in 1 CAN; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/01/2020
    Labeler - Alpha Hygiene LLC (063055824)
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