Label: HEALTH SMART ANTIBACTERIAL WET WIPES- benzethonium chloride swab

  • 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 July 5, 2015

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  • Active Ingredient(by volume)

    Benzethonium Chloride 0.3%

  • Purpose

    Antibacterial

  • Uses

    •decreases bacteria on skin.

  • WARNINGS

    For external use only.

  • Do not use:

    Over large areas of the body if you are allergic to any of the ingredients.

  • WHEN USING

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

  • STOP USE

  • ASK DOCTOR

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

  • Keep out of reach of children

    For children under 2 years ask a doctor before use. For children use under adult supervision.

  • Directions

    Do not expose to direct sunlight, preferably place them in a cool place. Do not use on furniture. Do not flush down toilets, dispose in a trash recepticals.

  • DOSAGE & ADMINISTRATION

    Remove lid and open the seal. Pull up the corner of the center sheet, twist it and thread through the dispenser split in the lid. Pull sheet out at an angle. When finished close the lid flap to retain moisture.

  • Inactive Ingredients

    Water, Propylene Glycol, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Fragrance, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, PEG-40 Hydrogenated Castor Oil, Cetrimonium Chloride, Citric Acid, Aloe Vera Extract, Alphatocopherol Acetate (Vitamin E)

  • SPL UNCLASSIFIED SECTION

    Health Smart TM

    Antibacterial Wet Wipes clean up grubby and sticky hands. When soap and water aren't handy. grab Health Smart TM Antibacterial Wet Wipes to kill bacteria and germs, wipe away grime, and get nice soft hands. Thanks to our Aloe & Vitamin E formula, they won't dry or irritate your skin like hand sanitizers can.

    Health Smart TM
    Antibacterial Wet Wipes can be used anytime, anywhere. Great for offices, schools, picnics, cars, shopping, travelling & camping.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    HOME SMART PRODUCTS
    PRODUCTS
    SOUTHFIELD, MI
    WWW.HOMESMARTPRODUCTS.COM
    MADE IN CHINA
    NDC #52862-100

  • Package Label

    HEALTH
    SMARTTM

    Enriched With
    Aloe Vera &
    Vitamin E

    Wet
    Wipes

    ANTIBACTERIAL
    FOR HANDS & FACE
    KILLS GERMS

    40 WIPES

    5.9" x 7.9" (15 CM X 20 CM)

    HS Wet Wipes label
  • INGREDIENTS AND APPEARANCE
    HEALTH SMART ANTIBACTERIAL WET WIPES 
    benzethonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.3 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-100-4040 in 1 CANISTER; Type 0: Not a Combination Product05/10/2013
    2NDC:52862-100-3030 in 1 PACKET; Type 0: Not a Combination Product05/10/2013
    3NDC:52862-100-1010 in 1 PACKET; Type 0: Not a Combination Product07/05/2015
    4NDC:52862-100-133 in 1 PACKAGE07/05/2015
    4NDC:52862-100-1010 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2013
    Labeler - International Wholesale, Inc. (161872676)
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