Label: DR.MOLLIS ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

  • Contains inactivated NDC Code(s)
    NDC Code(s):     79259-012-01, 79259-012-02, 79259-012-03, 79259-012-04, view more
    79259-012-05, 79259-012-06, 79259-012-07, 79259-012-08, 79259-012-09, 79259-012-10, 79259-012-11, 79259-012-12
  • Packager: TRUVA SERAMIK KOZMETIK TEMIZLIK PAZARLAMA MUTEAHHITLIK NAKLIYAT SANAYI VE TICARET LTD STI
  • 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 6, 2020

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  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    Name and amount of active substance (%):

    Alkyl (C12-16) dimethylbenzylammoniumchloride (ADBAC/BKC (C12-16)) (CAS No: 68424-85-1 / EC No: 270-325-2): %0.125

  • PURPOSE

    Purpose: Antibacterial

  • INDICATIONS & USAGE

    Use: Decreases bacteria on the skin

  • WARNINGS

    DO NOT EAT, DRINK OR USE ANYTHING DURING THE APPLICATION AND PREPARATION.

    FOLLOW USE INSTRUCTIONS TO PREVENT RISK ON HUMAN AND ENVIRONMENTAL HEALTH.

    KEEP AWAY FROM CHILDREN, FOOD and

  • DIRECTIONS FOR USE

    Lift lid and peel back sealing label. Pull top wipe through aperture in pack. Close lid after use to keep wipes moist.

  • STORAGE AND HANDLING

    Other Information: Use the unopened product within 2 months.

    Shelf life is 2 years if stored in room conditions.

  • Inactive Ingredients

    Aqua, Phenoxyethanol, Aloe Barbadensis Leaf juice, Glycerin, Propylene Glycol, Cocamidopropyl Betaine, Parfum, Benzyl Alcohol, Dehydroacetic Acid.

  • SPL UNCLASSIFIED SECTION

    Ministry of Health License Date and Number:

    harmful organisms will be used:

    IMAGE

    How to use: With its natural moisturizers, soft texture and structure that does not disturb the sensitive pH balance of your skin, it is a cleaning product that you can safely use in daily cleaning of all your family members.

    * Tested under laboratory conditions, S.aureus ATCC 6538; P.aeruginosa ATCC 15442; E.coli ATCC 10536; Efficacy proven against E.hirae ATCC 10541 bacteria.

    THE PRODUCT IS FOR GENERAL PUBLIC USE.

    READ THE LABEL AND GBF BEFORE USING.

    Formulation Form: Liquid absorbed into wipes

    Empty packaging disposal method: Dispose of this material and its container in accordance with national regulations.

    Product Type 1: Human Hygiene

    Poisoning symptoms: dizziness, nausea, vomiting

    Alkyl (C12-16) dimethylbenzylammoniumchloride (ADBAC/BKC (C12-16)) (CAS No: 68424-85-1) toksik doz bilgisi: LD50: 3.440 mg/kg(oral, sican) LD50: 3.440 mg/kg (dermal, tavsan)

    First aid measures: If inhaled, this route of exposure is not possible due to the physical nature of this product. Emergency medical attention is not required. If swallowed, the risk of swallowing is very low due to the physical properties of this product. Get medical attention if discomfort continues. In case of skin contact, wash with water. Get medical attention if discomfort continues. If in contact with eyes, if liquid has got into eyes, follow these steps: Wash with water. Get medical attention if discomfort continues.

    Antidote and necessary information: There is no specific antidote. Treatment is applied according to the symptoms.

    CALL 114NOUS PHONE OF NATIONAL POISON CONSULTING CENTER (UZEM) IN THE POISONING STATUS.

    Matters to be considered while using and storing the product:

    Keep out of the reach of children. Read and follow the manufacturer's recommendations. Keep away from food, drink and animal feedingstuffs. Wash hands thoroughly after handling. Store only in the original container in a cool, well-ventilated place. Protect from sunlight. It is poisonous to bees.

    Hazard Statements:

    T. C. It is not classified as harmful according to Regulation 28848.

    Üretici / Producer:

    TRUVA SERAMIK KOZMETIK TEM. PAZ. MÜT.NAK.SAN.TIC.LTD.ŞTI.

    Altınkale Mh. N. Hikmet Cd. 4152. Sk. No:2

    Döşemealti / ANTALYA / TÜRKİYE

    Tel: +90 242 421 25 30 Fax: +90 242 421 25 31

    info@pafilya.com.tr  www.pafilya.com.tr

    Üretim Yeri

    yeşilbayir Mah. Akdeniz Bulvari No: 99

    Döşemealti / ANTALYA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    DR.MOLLIS  ANTIBACTERIAL WET WIPES
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79259-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.125 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79259-012-0140 in 1 BAG07/06/2020
    14 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:79259-012-0215 in 1 BAG07/06/2020
    22.1 mL in 1 PATCH; Type 0: Not a Combination Product
    3NDC:79259-012-0360 in 1 BAG07/06/2020
    34 mL in 1 PATCH; Type 0: Not a Combination Product
    4NDC:79259-012-0472 in 1 BAG07/06/2020
    44 mL in 1 PATCH; Type 0: Not a Combination Product
    5NDC:79259-012-0580 in 1 BAG07/06/2020
    54.2 mL in 1 PATCH; Type 0: Not a Combination Product
    6NDC:79259-012-0690 in 1 BAG07/06/2020
    64.2 mL in 1 PATCH; Type 0: Not a Combination Product
    7NDC:79259-012-07100 in 1 BAG07/06/2020
    74.5 mL in 1 PATCH; Type 0: Not a Combination Product
    8NDC:79259-012-08120 in 1 BAG07/06/2020
    84.5 mL in 1 PATCH; Type 0: Not a Combination Product
    9NDC:79259-012-091 in 1 PACKET07/06/2020
    92.1 mL in 1 PATCH; Type 0: Not a Combination Product
    10NDC:79259-012-1020 in 1 BAG07/06/2020
    102.3 mL in 1 PATCH; Type 0: Not a Combination Product
    11NDC:79259-012-1125 in 1 BAG07/06/2020
    112.5 mL in 1 PATCH; Type 0: Not a Combination Product
    12NDC:79259-012-1250 in 1 BAG07/06/2020
    124 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/06/2020
    Labeler - TRUVA SERAMIK KOZMETIK TEMIZLIK PAZARLAMA MUTEAHHITLIK NAKLIYAT SANAYI VE TICARET LTD STI (504499920)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRUVA SERAMIK KOZMETIK TEMIZLIK PAZARLAMA MUTEAHHITLIK NAKLIYAT SANAYI VE TICARET LTD STI504499920manufacture(79259-012)
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