Label: SMART CARE ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride cloth

  • 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 September 7, 2023

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

  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.11%

  • Purpose

    Antibacterial

  • Uses

    decreases bacteria on skin

  • Warnings

    For external use only

    Do not use if you are allergic to any of the ingredients

    When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

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

  • Directions

    • Adults and children 2 years and older: Wipe hands thorough with product and allow to dry without wiping.
    • Children under 2 years of age: Consult a doctor before use.
  • Inactive ingredients

    Water, Alcohol, Propylene Glycol, Phenoxyethanol, Lauryl Glucoside, Tetrasodium EDTA, 2-Bromo-2-Nitropropane-1,3-Diol, Citric Acid, Fragrance, Iodopropynyl Butylcarbamate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract.

  • Questions or comments?

    Call toll free 1-877-274-8358

  • SPL UNCLASSIFIED SECTION

    SOFT & REFRESHING WITH ALOE & CHAMOMILE

    KILLS 99.9% OF GERMS*

    HYPOALLERGENIC

    GREAT FOR:
    CAMPING
    HIKING
    TRAVEL

    DO NOT FLUSH

    EACH 5 IN. X 6.89 IN. (12.7 cm X 17.5 cm)

    Antibacterial Hand Wipes

    Kills 99.9% of germs* and wipes away dirt and from hands. The wipes are gentle on skin and specially formulated to be tough on dirt and germs. Ideal for a quick clean-up from contact with dirt, sticky food and other everyday messes. These soft wipes have a fresh and clean scent and are formulated with a touch of aloe and chamomile. The hard closure lid helps retain the wipes moisture between uses.

    To Dispense Wipe:• Pull out wipe from center of roll
    • Feed wipe through guide
    • Pull wipe toward you
    • Ensure lid closes securely to retain wipe moisture

    To Dispose Wipe:• Place used wipes in a waste basket after use.

    PLEASE DISPOSE AFTER USE

    DESIGNED IN U.S.A. 

    MADE IN CHINA

    COMMENTS? / QUESTIONS?
    1-877-274-8358 TOLL FREE IN U.S.A.
    1-909-434-0911 INTERNATIONAL PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

    DISTRIBUTED BY:
    ASHTEL STUDIOS INC. • ONTARIO, CALIFORNIA 91761

    SMARTCAREUS.COM

    *Effective at killing 99.9% Escherichia coil, Staphylococcus aureus.

  • Packaging

    Smartcare77-2

  • INGREDIENTS AND APPEARANCE
    SMART CARE ANTIBACTERIAL HAND SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.11 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-077-0175 in 1 CANISTER09/06/2023
    13.11 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/06/2023
    Labeler - Ashtel Studios, Inc. (148689180)