Label: ANTISEPTIQUE ADVANCE STRENGTH- alcohol spray

  • 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 March 25, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 80% v/v

  • Purposes

    Antiseptic handwash

  • Uses

    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 eyes | on children less than 2 months old | 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 skin irritation or rash occurs. There may be signs of a serious conditions.

    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 15-30°C (59-86°F), Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive Ingredients

    Purified Water USP, Glycerin, Hydrogen Peroxide

  • Questions?

    Email: sales@tri-pac.us

  • PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

    ANTISEPTIQUE+
    ADVANCED STRENGTH
    sanitizer mist

    Alcohol Antiseptic 80%
    Topical Non-sterile Solution

    2 FL. OZ. (59 ML)

    PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIQUE ADVANCE STRENGTH 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72138-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 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:72138-420-2059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/20/2020
    2NDC:72138-420-40118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/20/2020
    3NDC:72138-420-60177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/20/2020
    4NDC:72138-420-16472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E03/19/2020
    Labeler - Hubot Healthcare LLC (081084880)
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