FDA.reportPublic FDA data

Dr.Mollis

Manufacturer
TRUVA SERAMIK KOZMETIK TEMIZLIK PAZARLAMA MUTEAHHITLIK NAKLIYAT SANAYI VE TICARET LTD STI
Effective date
2020-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:16

Label at a glance#

ProductDr.Mollis Antibacterial Wet Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Antibacterial

INDICATIONS & USAGE SECTION

Use: Decreases bacteria on the skin

WARNINGS SECTION

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP AWAY FROM CHILDREN, FOOD and

DIRECTIONS FOR USE

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other Information: Use the unopened product within 2 months.

Shelf life is 2 years if stored in room conditions.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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:

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2276303benzalkonium Cl 0.125 % Medicated PadPSN1
2276303benzalkonium chloride 1.25 MG/ML Medicated PadSCD1
2276303benzalkonium chloride 0.125 % Medicated WipeSY1
2276303benzalkonium chloride 0.125 % Topical ClothSY1
2276303benzalkonium chloride 0.125 % Topical SwabSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79259-012-012021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-022021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-032021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-042021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-052021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-062021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-072021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-082021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-092021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-102021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-112021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes
79259-012-122021-07-23C16284748780-1c7ccaba7-14c4-fd44-e053-dadaa90aa01bDr. Mollis Antibacterial Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79259-012-01Dr.MollisAntibacterial Wet Wipes4 mL in 1 PATCHCLOTH41
79259-012-01Dr.MollisAntibacterial Wet Wipes40 in 1 BAGCLOTH401
79259-012-02Dr.MollisAntibacterial Wet Wipes15 in 1 BAGCLOTH151
79259-012-02Dr.MollisAntibacterial Wet Wipes2.1 mL in 1 PATCHCLOTH2.11
79259-012-03Dr.MollisAntibacterial Wet Wipes4 mL in 1 PATCHCLOTH41
79259-012-03Dr.MollisAntibacterial Wet Wipes60 in 1 BAGCLOTH601
79259-012-04Dr.MollisAntibacterial Wet Wipes72 in 1 BAGCLOTH721
79259-012-04Dr.MollisAntibacterial Wet Wipes4 mL in 1 PATCHCLOTH41
79259-012-05Dr.MollisAntibacterial Wet Wipes80 in 1 BAGCLOTH801
79259-012-05Dr.MollisAntibacterial Wet Wipes4.2 mL in 1 PATCHCLOTH4.21
79259-012-06Dr.MollisAntibacterial Wet Wipes4.2 mL in 1 PATCHCLOTH4.21
79259-012-06Dr.MollisAntibacterial Wet Wipes90 in 1 BAGCLOTH901
79259-012-07Dr.MollisAntibacterial Wet Wipes4.5 mL in 1 PATCHCLOTH4.51
79259-012-07Dr.MollisAntibacterial Wet Wipes100 in 1 BAGCLOTH1001
79259-012-08Dr.MollisAntibacterial Wet Wipes120 in 1 BAGCLOTH1201
79259-012-08Dr.MollisAntibacterial Wet Wipes4.5 mL in 1 PATCHCLOTH4.51
79259-012-09Dr.MollisAntibacterial Wet Wipes2.1 mL in 1 PATCHCLOTH2.11
79259-012-09Dr.MollisAntibacterial Wet Wipes1 in 1 PACKETCLOTH11
79259-012-10Dr.MollisAntibacterial Wet Wipes20 in 1 BAGCLOTH201
79259-012-10Dr.MollisAntibacterial Wet Wipes2.3 mL in 1 PATCHCLOTH2.31
79259-012-11Dr.MollisAntibacterial Wet Wipes25 in 1 BAGCLOTH251
79259-012-11Dr.MollisAntibacterial Wet Wipes2.5 mL in 1 PATCHCLOTH2.51
79259-012-12Dr.MollisAntibacterial Wet Wipes50 in 1 BAGCLOTH501
79259-012-12Dr.MollisAntibacterial Wet Wipes4 mL in 1 PATCHCLOTH41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79259-012DR.MOLLIS ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [TRUVA SERAMIK KOZMETIK TEMIZLIK PAZARLAMA MUTEAHHITLIK NAKLIYAT SANAYI VE TICARET LTD STI]1Legacy NDC, 24 package rows20200715_314abf08-2588-4b76-8f1e-b30642333304.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79259-01279259-012-01, 79259-012-02, 79259-012-03, 79259-012-04, 79259-012-05, 79259-012-06, 79259-012-07, 79259-012-08, 79259-012-09, 79259-012-10, 79259-012-11, 79259-012-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZYL ALCOHOLLKG8494WBHIACT
DEHYDROACETIC ACID2KAG279R6RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8f6c1684-c956-4362-98c3-0def8265f610314abf08-2588-4b76-8f1e-b306423333042020-07-06WarningsExact identifier
spl id: 8f6c1684-c956-4362-98c3-0def8265f610
spl set id: 314abf08-2588-4b76-8f1e-b30642333304

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.