Label: SMART CARE ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid

  • 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 26, 2021

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.2% w/w

  • Purpose

    Antiseptic

  • Use

    • For washing hands to decrease bacteria on hands
  • Warnings

    For external use only

    Do not use • on open skin wounds

    When using this product • avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if • irritation and redness develop

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

  • Directions

    Pump onto wet hands, vigorously work into a lather, and rinse thoroughly

  • Other information

    • Store in a cool dry place below 104°F
  • Inactive ingredients

    water, cocamidopropyl betaine, cocamidopropylamine oxide, lauryl glucoside, cocamide DEA, glycerin, PEG-150 distearate, fragrance, disodium EDTA, benzophenone-4, citric acid, sodium chloride, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, FD&C blue no. 1, FD&C yellow no. 5, FD&C yellow no. 6, ext. D&C violet no. 2, FD&C red no. 40

  • Questions or Comments?

    1-877-274-8358 Toll Free in USA • 1-909-434-0911 International

  • SPL UNCLASSIFIED SECTION

    KILLS UP TO 99% OF MOST COMMON GERMS

    CUCUMBER & TEA

    LAVENDER

    TROPICAL BEACH

    SWEET PEACH

    DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761

    PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

    DESIGNED IN USA • MADE IN CHINA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SMART CARE ANTIBACTERIAL HANDSOAP 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74416-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1809 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74416-006-01400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/13/2021
    Labeler - Guangzhou C-kang Biotechnology Co., Ltd. (415992294)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou C-kang Biotechnology Co., Ltd.415992294manufacture(74416-006)
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