Label: DR.CLINIC ANTIBACTERIAL WET WIPES ALCOHOL FREE- benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL

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 1, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Name and amount of active substance (%)(w/w)

    (Chemical name; CAS Number)

    Benzalkonium Chloride CAS No: 85409-22-9 (0.2%)

  • Purpose

    Antibacterial

  • Uses:

    • hand wipes to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available
  • Warnings:

    FROM CHILDREN, FOOD AND ANIMAL KEEP AWAY FROM FEEDS.
    IN APPLICATION AND PREPARATION DO NOT EAT, DRINK, OR USE SMOKING.
    RISKS ON HUMAN AND ENVIRONMENTAL HEALTH
    TO AVOID, INSTRUCTIONS FOR USE FOLLOW. It is poisonous to bees.
    It can be poisonous to fish and aquatic organisms.

    Keep out of reach of children.

  • How to use:

    Take as much wet wipes as you need to clean your skin and gently clean. The product is a product developed for personal hygiene. You can use the product as often as you like.! It has a lethal effect on bacteria.

  • Auxiliary components% (w/w)(99.80)

    Aqua, Vegetable Oil, Glycerin, Lauryl Glucoside, Polyglyceryl-2- Dipolihydroxystearate, Glyceryl Oleate, Dicaprylyl Carbonate, Perfume, Triethanolamine.

  • SPL UNCLASSIFIED SECTION

    ANTI - FUNGAL

    Bacteria %99.9 Kills Of Germs

    Product shelf life is 2 years.
    Consume within 3 months of opening the packaging.
    BIOSIDAL PRODUCT

    Empty packaging disposal method:
    Empty packages should be sent for recycling or waste disposal.

    PRODUCT TYPE 1
    Biocidal product related to human hygiene. Antibacterial hand cleaning wipes.
    Symptoms of poisoning.


    Benzalkonium chloride LD50 (oral, rat): 795 mg / kg
    First Aid Measures
    In case of inhalation: There is no danger in case of inhalation.
    In case of eye contact: Rinse carefully with water for several minutes. Remove contact lenses if they are attached and easy to do. Continue rinsing.
    In case of skin contact: This product is intended to come in contact with the skin. Wash excess with water. Get medical attention if redness, swelling, itching, or burning occur.
    In case of swallowing: Rinse mouth. Do not try to abuse. If unconscious, never give anything by mouth. If it is vomiting, lay it on its back and turn it on its side.
    It has no specific antidote.
    CALL 114NOUS PHONE OF NATIONAL POISON CONSULTING CENTER (UZEM) IN THE POISONING CONDITIONS.
    MATTERS TO BE CONSIDERED WHEN USING AND STORING THE PRODUCT


    HAZARDOUS EXPRESSION AND EXPLANATION
    According to the Official Gazette No. 28848 (R.G 11.12.2013-28848) Local regulations are not classified as harmful under SEA and EU directives 1272/2008 / EC [CLP / GHS].

    PRECAUTIONARY STATEMENT AND EXPLANATION
    P301 + P330 + P331 IF SWALLOWED: Rinse mouth. DO NOT try to abuse it. P305 + P351 + P338 IF IN EYES:
    Rinse carefully with water for several minutes. Remove contact lenses if they are attached and easy to do. Continue rinsing. P273: Avoid release to the environment. P391: Collect spillages. P101: If medical advice is needed, have product container or label ready. P102: Keep out of the reach of children. P103: Read the label before use. Storage; P410 + P235: Please do not expose to sunlight, store in a cool dry place.

    Name and address of the owner of the manufacturer:
    MAKYAJ KOZMETIK INSAAT SANAYI TICARET LIMITED SIRKETI
    Hadımköy Baglantı Yolu Akçaburgaz Mah. No: 140
    Esenyurt/ Istanbul
    Name and address of the license holder:
    MAKYAJ KOZMETIK INSAAT SANAYI TICARET LIMITED SIRKETI
    Hadımköy Baglantı Yolu Akçaburgaz Mah. No: 140
    Esenyurt/ Istanbul

    USER GROUP
    (PERSONAL AND HUMAN USE)

    BEFORE USING, READ THE LABEL AND THE PROCEDURE
    COMPANY NAME AND EMBLEM
    MAKYAJ COSMETIC CONSTRUCTION INDUSTRY AND TRADE COMPANY LIMITED

  • Packaging

    untitleduntitled

  • INGREDIENTS AND APPEARANCE
    DR.CLINIC ANTIBACTERIAL WET WIPES ALCOHOL FREE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76725-004
    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:76725-004-011 in 1 PACKAGE06/02/2020
    14.17 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:76725-004-0212 in 1 PACKAGE06/02/2020
    24.17 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:76725-004-0340 in 1 PACKAGE06/02/2020
    34.17 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:76725-004-0472 in 1 PACKAGE06/02/2020
    44.17 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2020
    Labeler - MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI (504546402)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI504546402manufacture(76725-004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!