Label: ANTISEPTIQUE SANITIZER MIST- 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 June 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 65% v/v

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

    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 | Supervise children under 6 years of age when using this product to avoid swallowing.

  • 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| Store between 15-30C (59-86F) | Avoid freexing and excessive heat above 40C (104F)

  • Inactive Ingredients

    water (aqua), glycerin,, safflower oil, hydrogenated castor oil, almond oil, coconut oil, jojoba oil, lavender oil

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

    ANTISEPTIQUE+
    sanitizer mist

    antiseptic | rinse-free | 65% alcohol

    FOR HANDS
    dye free, fragrance free

    2 FL. OZ. (59 ML)

    PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIQUE SANITIZER MIST 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72138-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Safflower Oil (UNII: 65UEH262IS)  
    Almond Oil (UNII: 66YXD4DKO9)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Jojoba Oil (UNII: 724GKU717M)  
    Spike Lavender Oil (UNII: 7S2HYV1VJQ)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72138-400-2059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/22/2020
    2NDC:72138-400-40118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/22/2020
    3NDC:72138-400-80236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/22/2020
    4NDC:72138-400-60174 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/22/2020
    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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