FRESH N SOFT ANTIBACTERIAL WET WIPES

Manufacturer
KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI
Effective date
2020-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:08

Label at a glance#

ProductFRESH N SOFT ANTIBACTERIAL WET WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

• Gently open resealable label, remove and use wipes as required. Keep label closed to prevent moisture loss. • No need to rinse after usage. Allow skin to dry without wiping. • For adults and children 2 years and over. • Discard properly after use. • Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

• Store in dry and cool place. • Production date, expiry date and lot number are printed on the pack.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride (0.1%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Decreases bacteria on the skin that could cause disease

Warnings

WARNINGS SECTION

For external use only.

• Do not use as baby wipe.

• Do not use if you are allergic to any of the ingredients.

• Do not use on open skin wounds.

When using this products

• Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

• Stop use and ask a doctor if irritation or allergic reaction occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Gently open resealable label, remove and use wipes as required. Keep label closed to prevent moisture loss.

• No need to rinse after usage. Allow skin to dry without wiping. • For adults and children 2 years and over. • Discard properly after use. • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

• Store in dry and cool place.
• Production date, expiry date and lot number are printed on the pack.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, phenoxyethanol, propylene glycol, parfum, cocamidopropyl betaine, peg-40 hydrogenated castor oil, benzoic acid, tetrasodium edta, dehydroacetic acid, sodium hydroxide

SPL UNCLASSIFIED SECTION

DERMATOLOGICALLY TESTED

EN 1276

KARDESLER

UCAN YAGLAR SANAYI A.S.

1957

MANUFACTURER
KARDESLER UÇAN YAGLAR SANAYI A.S.

INÖNÜ MAHALLESI GEBZE
PLASTIKÇILER OSB MAHALLESI
42.SOKAK NO:1 41400
GEBZE - KOCAELI - TÜRKIYE
T +90 ( 0262 ) 751 29 30
www.kardeslerucanyaglar.com
info@kardeslerucanyaglar.com

www.freshnsoft.com

FreshnSoft

FreshnSoft

ISO 22716 Good Manufacturing Practices

ISO 9001 Quality Management System

EAC Made in Turkey.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN1
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD1
1038856benzalkonium chloride 0.1 % Medicated WipesSY1
1038856benzalkonium chloride 0.1 % Topical SwabSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86937-005-01FRESH N SOFT ANTIBACTERIAL WET WIPES2.688 g in 1 PACKAGECLOTH2.6881
86937-005-01FRESH N SOFT ANTIBACTERIAL WET WIPES15 in 1 PACKETCLOTH151
86937-005-02FRESH N SOFT ANTIBACTERIAL WET WIPES3.192 g in 1 PACKAGECLOTH3.1921
86937-005-02FRESH N SOFT ANTIBACTERIAL WET WIPES60 in 1 PACKETCLOTH601
86937-005-03FRESH N SOFT ANTIBACTERIAL WET WIPES2.9792 g in 1 PACKAGECLOTH2.97921
86937-005-03FRESH N SOFT ANTIBACTERIAL WET WIPES80 in 1 CANISTERCLOTH801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86937-005FRESH N SOFT ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI]1Legacy NDC, 6 package rows20201231_10d21a95-b74f-4a10-984b-c6e350281e6d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86937-00586937-005-01, 86937-005-02, 86937-005-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
a67e780c-3176-4180-aec8-ccf0c5a46ae510d21a95-b74f-4a10-984b-c6e350281e6d2020-12-23WarningsExact identifier
spl id: a67e780c-3176-4180-aec8-ccf0c5a46ae5
spl set id: 10d21a95-b74f-4a10-984b-c6e350281e6d

Reported adverse events (FAERS/openFDA)#

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