Label: ALCARE FOAMED ANTISEPTIC HANDRUB- alcohol aerosol, foam

  • NDC Code(s): 11084-801-36, 11084-801-57
  • Packager: SC Johnson Professional USA, Inc.
  • 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 December 11, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Ethyl Alcohol 62% v/vSurgical Scrub
    Healthcare Personnel Handwash/Antiseptic Handwash
  • Uses

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

    For external use only.

    Flammable. Keep away from fire or flame.

    When using this product

    • avoid contact with eyes. If splashed in eyes, rinse promptly and thoroughly with water.
    • do not puncture or incinerate; contents under pressure.

    Stop use and ask a doctor if

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

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • 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/Antiseptic Handwash Apply product to hands and rub until thoroughly dry.
  • Other information

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

  • Inactive ingredients

    Aqua (Water), Hydrofluorocarbon 152A, Isobutane, Emulsifying Wax, Propane

  • Questions or comments?

    1-866-783-0422

  • PRINCIPAL DISPLAY PANEL - 153 g Can Label

    SCJ PROFESSIONAL
    HEALTHCARE

    Alcare®

    NDC 11084-801-57

    Hand Sanitizer
    Foamed Antiseptic Handrub

    Moisturization

    15
    seconds
    Fast Acting

    CHG Compatible

    Net Weight: 153 g (5.4 oz)
    SAP # 4000000091

    Manufactured for:
    SC Johnson Professional USA, Inc
    Charlotte, NC 28217
    1-866-783-0422 www.scjp.com
    Pat. www.scjp.com/patents

    REORDER #
    6395-57

    deb
    SKIN CARE

    Principal Display Panel - 153 g Can Label
  • INGREDIENTS AND APPEARANCE
    ALCARE FOAMED ANTISEPTIC HANDRUB 
    alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
    ISOBUTANE (UNII: BXR49TP611)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPANE (UNII: T75W9911L6)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-801-57153 g in 1 CAN; Type 0: Not a Combination Product02/01/2018
    2NDC:11084-801-36255 g in 1 CAN; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E02/01/2018
    Labeler - SC Johnson Professional USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra Pac, Inc.024213616MANUFACTURE(11084-801)
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