DR.MOLLIS ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

Dr.Mollis by

Drug Labeling and Warnings

Dr.Mollis by is a Otc medication manufactured, distributed, or labeled by TRUVA SERAMIK KOZMETIK TEMIZLIK PAZARLAMA MUTEAHHITLIK NAKLIYAT SANAYI VE TICARET LTD STI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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

INGREDIENTS AND APPEARANCE

DR.MOLLIS  ANTIBACTERIAL WET WIPES
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79259-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.125 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79259-012-01	40 in 1 BAG	07/06/2020
1		4 mL in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 79259-012-02	15 in 1 BAG	07/06/2020
2		2.1 mL in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 79259-012-03	60 in 1 BAG	07/06/2020
3		4 mL in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 79259-012-04	72 in 1 BAG	07/06/2020
4		4 mL in 1 PATCH; Type 0: Not a Combination Product
5	NDC: 79259-012-05	80 in 1 BAG	07/06/2020
5		4.2 mL in 1 PATCH; Type 0: Not a Combination Product
6	NDC: 79259-012-06	90 in 1 BAG	07/06/2020
6		4.2 mL in 1 PATCH; Type 0: Not a Combination Product
7	NDC: 79259-012-07	100 in 1 BAG	07/06/2020
7		4.5 mL in 1 PATCH; Type 0: Not a Combination Product
8	NDC: 79259-012-08	120 in 1 BAG	07/06/2020
8		4.5 mL in 1 PATCH; Type 0: Not a Combination Product
9	NDC: 79259-012-09	1 in 1 PACKET	07/06/2020
9		2.1 mL in 1 PATCH; Type 0: Not a Combination Product
10	NDC: 79259-012-10	20 in 1 BAG	07/06/2020
10		2.3 mL in 1 PATCH; Type 0: Not a Combination Product
11	NDC: 79259-012-11	25 in 1 BAG	07/06/2020
11		2.5 mL in 1 PATCH; Type 0: Not a Combination Product
12	NDC: 79259-012-12	50 in 1 BAG	07/06/2020
12		4 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/06/2020

Labeler - TRUVA SERAMIK KOZMETIK TEMIZLIK PAZARLAMA MUTEAHHITLIK NAKLIYAT SANAYI VE TICARET LTD STI (504499920)

Establishment
Name	Address	ID/FEI	Business Operations
TRUVA SERAMIK KOZMETIK TEMIZLIK PAZARLAMA MUTEAHHITLIK NAKLIYAT SANAYI VE TICARET LTD STI		504499920	manufacture(79259-012)