Label: INSTANT 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 January 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin without soap and water
  • Warnings

    For external use only. Flammable, keep away from fire or flame

    When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

    Stop use and ask doctor if

    • irritation and redness develops and 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 a small amount and rub over both hands & wrists until dry
    • allow to dry without wiping
    • children under 6 should be supervised while using this product
  • Inactive Ingredients

    aloe vera, carbomer, fragrance, purified water, triethanolamine

    Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA
    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label

    Henry Schein

    112-5991

    Maxiclens

    Instant Hand Sanitizer

    NDC 0404-5991-01

    27.05 FL. OZ. (800 ML)

    PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-5991
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe (UNII: V5VD430YW9)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-5991-01800 mL in 1 BOX; Type 0: Not a Combination Product02/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2012
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0404-5991)
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