Label: ANTISEPTIQUE PLUS- 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 March 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 62.5% w/w

  • Purposes

    Antiseptic handwash

  • Uses

    for handwashing to decrease bacteria on the skin

  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame, heat, sparks, and sources of static discharge

    Do not use

    • In eyes

    When using this product

    • If in eyes, rinse promptly and thoroughly with water
    • Discontinue use if irritation and redness develops

    Stop use and ask a doctor if skin irritation or redness occurs or 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

    • Apply product onto hands, spread thoroughly and rub dry
  • Other Information

    • For additional information, see Safety Data Sheets (SDS)
    • For emergency medical information in USA and Canada, call 1-888-255-3924
    • For emergency medical information worldwide, call 1-813-248-0573
  • Inactive Ingredients

    water (aqua), ethyl acrylate/ methacrylic acid/ steareth-20 methacrylate copolymer, aminomethylpropanediol, ppg-14 butyl ether, tocopherol acetate, aloe barbadensis leaf juice

  • Questions?

    Call 1-855-CLEAN-55 (253-2655)

  • PRINCIPAL DISPLAY PANEL - 473 ML Bottle Label

    ANTISEPTIQUE+
    PLUS
    gel sanitizer

    antiseptic | rinse-free | 62.5% alcohol

    FOR HANDS
    dye free, fragrance free

    16 FL. OZ. (473 ML)

    PRINCIPAL DISPLAY PANEL - 473 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIQUE PLUS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72138-470
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72138-470-06177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/13/2020
    2NDC:72138-470-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/13/2020
    3NDC:72138-470-32946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E03/13/2020
    Labeler - Hubot Healthcare LLC (081084880)
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