Label: INSTANT HAND SANITIZER- alcohol gel

  • NDC Code(s): 0404-5988-01, 0404-5988-02, 0404-5988-03, 0404-5988-04
  • Packager: Henry Schein, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Ethyl Alcohol 66.5%

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  • Purpose

    Antiseptic

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  • Uses

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

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  • 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
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  • Inactive Ingredients

    aloe vera, carbomer, fragrance, purified water, triethanolamine

    Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA

    Made in U.S.A.

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  • PRINCIPAL DISPLAY PANEL – 800 mL Box Label

    Henry Schein

    112-5988

    Maxiclens

    Instant Hand Sanitizer

    NDC 0404-5988-01

    27.05 FL. OZ. (800 ML)

    PRINCIPAL DISPLAY PANEL – 800 mL Box Label
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  • PRINCIPAL DISPLAY PANEL – 1.68 mL Pouch

    Henry Schein

    Maxiclens

    Instant Hand

    Sanitizer

    Citrus Scent

    To Order: Contact your

    Henry Schein Sales Rep

    0.0570 fl.oz. (1.68 ML)

    Distributed by

    HENRY SCHEIN, Inc.

    Melville, NY 11747 USA

    Made in U.S.A.

    PRINCIPAL DISPLAY PANEL – 1.68 mL Pouch
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  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0404-5988
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    alcohol (alcohol) alcohol 665 mL  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    aloe  
    water  
    trolamine  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0404-5988-01 800 mL in 1 BOX
    2 NDC:0404-5988-02 1.68 mL in 1 POUCH
    3 NDC:0404-5988-03 237 mL in 1 BOTTLE, PUMP
    4 NDC:0404-5988-04 473 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 02/07/2012
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(0404-5988)
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