Label: ALCARE PLUS FOAMED ANTISEPTIC HANDRUB- alcohol aerosol, foam 

  • Label RSS
  • NDC Code(s): 0519-6399-35, 0519-6399-36, 0519-6399-55, 0519-6399-57, view more
    0519-6399-75, 0519-6399-76, 0519-6399-80, 0519-6399-90
  • Packager: STERIS Corporation
  • 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 02/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    62% v/v Ethyl Alcohol

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  • Purposes

    Antiseptic

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  • Uses

    • Surgical Scrub significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
    • Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.
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  • Warnings

    Flammable, keep away from fire or flame.

    For external use only. Avoid contact with eyes. Eye irritant. If splashed in eyes, rinse promptly and thoroughly with water.

    Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Contents under pressure. Do not puncture or incinerate. Do not store above 120°F (49°C). For best foam density store and use at 55 - 85°F (13 - 29°C).

    Discontinue use if irritation and redness develop. If irritation persists for more than 3 days, consult a physician.

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  • Directions

    Surgical Scrub

    Clean under nails with a pick. Nails should be maintained with a 1 mm free edge. Dispense 5 grams (tennis ball) onto one hand. Spread on both hands, paying particular attention to the nails, cuticles, and interdigital spaces and forearms. Rub into skin until dry. Dispense 2.5 grams (golf ball) onto one hand and spread over both hands to the wrists and rub into the skin until dry.

    Healthcare Personnel Handwash

    Apply product to hands and rub until thoroughly dry.

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  • Inactive ingredients

    Water, Hydrofluorocarbon 152A, Isobutane, Emulsifying Wax, Polyquaternium-6, Sodium Benzoate, Propane, Sodium Sesquicarbonate

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  • Questions or comments?

    800-548-4873

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  • PRINCIPAL DISPLAY PANEL - 255 g Can Label

    Alcare® Plus

    Foamed
    Antiseptic
    Handrub

    NDC 0519-6399-36

    Hand Sanitizer

    Excellent
    Moisturization

    15
    seconds

    Fast-acting

    CHG Compatible

    Manufactured for:
    STERIS Corporation
    7501 Page Avenue
    St. Louis, MO 63133 ■ USA
    800-548-4873 www.steris.com

    For Hospital and Professional Use Only.

    Net Weight: 255g (9 oz)

    STERIS®

    REORDER #
    6399-36

    6399-35P(1013)
    52225
    Product Made in U.S.A.

    Principal Display Panel - 255 g Can Label
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  • INGREDIENTS AND APPEARANCE
    ALCARE PLUS FOAMED ANTISEPTIC HANDRUB 
    alcohol aerosol, foam
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0519-6399
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    alcohol (alcohol) alcohol 62 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    water  
    1,1-Difluoroethane  
    Isobutane  
    Cetostearyl Alcohol  
    Polysorbate 60  
    Sodium Benzoate  
    Propane  
    Sodium Sesquicarbonate  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0519-6399-75 48 in 1 CASE
    1 NDC:0519-6399-76 62.4 g in 1 CAN
    2 NDC:0519-6399-55 24 in 1 CASE
    2 NDC:0519-6399-57 153 g in 1 CAN
    3 NDC:0519-6399-35 24 in 1 CASE
    3 NDC:0519-6399-36 255 g in 1 CAN
    4 NDC:0519-6399-90 12 in 1 CASE
    4 NDC:0519-6399-80 482 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333E 09/01/2011
    Labeler - STERIS Corporation (139424188)
    Establishment
    Name Address ID/FEI Business Operations
    Accra Pac, Inc. 024213616 MANUFACTURE(0519-6399)
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