Label: ALCARE ANTISEPTIC HANDRUB- alcohol liquid

  • NDC Code(s): 11084-035-18, 11084-035-27
  • 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 June 16, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol, 70% v/v

  • Purpose

    Antibacterial

  • Uses

    • for hand sanitizing to reduce bacteria on the skin
  • Warnings

    For external use only

    Flammable: Keep away from fire or flame.

    When using this product

    • avoid contact with eyes. In case of eye contact, flush with water

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply sanitizer to cover hands
    • rub into skin
    • no rinsing required
  • Inactive ingredients

    aqua (water), glycerin, hydroxypropyl cellulose, panthenol, parfum (fragrance), trisodium dicarboxymethyl alaninate.

  • PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

    SCJ PROFESSIONAL
    HEALTHCARE

    Alcare®

    NDC 11084-035-27

    Antiseptic Handrub Liquid

    Excellent Moisturization

    Net Contents: 1 Liter (33.8 fl oz)
    SAP # 4000009648

    REORDER #
    ALCELV100
    L-1448 RO

    deb
    SKIN CARE

    PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label
  • INGREDIENTS AND APPEARANCE
    ALCARE ANTISEPTIC HANDRUB 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.94 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TRISODIUM DICARBOXYMETHYL ALANINATE (UNII: 784K2O81WY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-035-271000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2021
    2NDC:11084-035-18370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/01/2021
    Labeler - SC Johnson Professional USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    SC Johnson Professional CA Inc.203765300MANUFACTURE(11084-035)
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