Label: DR CLINIC ANTIBACTERIAL WET 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 10, 2020

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride (0.2%)

  • Purpose

    Antiseptic

  • Uses

    • For hand sanitizing to decrease bacteria and germs on skin.

    • Apply topically to the skin to help prevent cross contamination.

    • Not Recommended for repeated use.

    • Dries in seconds.

  • Warnings

    • For external use only. Harmful if swallowed.

    • Do not use as baby wipes.

    • Do not use in or contact the eyes.

    Avoid contact with open or exposed wounds

    When Using 

    Keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water

    Stop Use

    Stop use if too much skin irritation and sensitivity develops or increases

    KEEP OUT OF REACH OF CHILDREN 

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

  • Directions

    • Open lid, gently peel back resealable label, remove and use wipes as required 

    • Reseal after use to avoid evaporation of alcohol it is a violation of federal law to use this product in a manner inconsistent with its labeling.

  • Other Informations

    • Store at room temperature 15-30°C (59-86°F).

    • Lot No. Manufacture date and expiration date can be found on package.

  • Inactive Ingredients

    Aqua, Olus Oil, Glycerin, Lauryl Glucoside, Polyglyceryl-2- Dipolihydroxystearate, Glyceryl Oleate, Dicapyryl Carbonate, Perfume, Triethanolamine

  • SPL UNCLASSIFIED SECTION

    ANTIBACTERIAL

    ANTI-FUNGAL

    Kills 99.9% Bacteria & Germs

    pH 5.5

    BLEACH FREE

    Distributed by IVI

    200 Blydenburg Rd.

    Unit 3 - Islandia NY 11749

    Email:info@drclinicusa.com

    Phone: (800)686-5044 

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    DR CLINIC ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76725-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76725-013-01100 in 1 PACKET09/10/2020
    12.5 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/10/2020
    Labeler - MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI (504546402)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI504546402manufacture(76725-013)
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