FDA.reportPublic FDA data

FRESHMAKER ANTISEPTIC WET WIPES

Manufacturer
FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:06

Label at a glance#

ProductFRESHMAKER ANTISEPTIC WET WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

open resealable label. Pull out wipes. Close resealable label to prevent drying out wipe hands thoroughly with product and allow to dry dispose the wipe after use supervise children under 6 years of age when using this product to avoid swallowing  do not flush

Storage and handling

store between 15-30˚C(59-86˚F) avoid freezing and excessive heat above 40˚C(104˚F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • open resealable label. Pull out wipes. Close resealable label to prevent drying out
  • wipe hands thoroughly with product and allow to dry
  • dispose the wipe after use
  • supervise children under 6 years of age when using this product to avoid swallowing 
  • do not flush

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30˚C(59-86˚F)
  • avoid freezing and excessive heat above 40˚C(104˚F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, citric acid, cocamidopropyl betaine, dehydroacetic acid, fragrance, glycerin, PEG-7 glyceryl cocoate, phenoxyethanol, polysorbate 20, propylene glycol, tetrasodium EDTA, water

SPL UNCLASSIFIED SECTION

ANTISEPTIC AGENT

BENZALKONIUM CHLORIDE

Manufactured by : Fulya Kozmetik Islak Mendil Iml. ve Paz.Ltd.Sti.

Kirac Osmangazi Kucuk Ayazma Street No:17

34522, Esenyurt/ISTANBUL/TURKEY

P: +90 212 689 28 28 Fax: +90 212 689 82 28

Made in TURKEY

Web: www.fulyakozmetik.com

e-mail: fulya@fulyakozmetik.com.tr

Lot No:

Expiry:

You may also report any serious side effects to 

PO BOX 328, Wood Ridge, NJ 07075-328

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78850-120-002022-01-28C16284748780-1d6a99b39-5d10-a426-e053-dadaa90af4c2Freshmaker ANTISEPTIC HAND WIPES
78850-120-152022-01-28C16284748780-1d6a99b39-5d10-a426-e053-dadaa90af4c2Freshmaker ANTISEPTIC HAND WIPES
78850-120-722022-01-28C16284748780-1d6a99b39-5d10-a426-e053-dadaa90af4c2Freshmaker ANTISEPTIC HAND WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78850-120-00FRESHMAKER ANTISEPTIC WET WIPES3.6 g in 1 PACKAGECLOTH3.61
78850-120-00FRESHMAKER ANTISEPTIC WET WIPES120 in 1 PACKETCLOTH1201
78850-120-15FRESHMAKER ANTISEPTIC WET WIPES2.87 g in 1 PACKAGECLOTH2.871
78850-120-15FRESHMAKER ANTISEPTIC WET WIPES15 in 1 PACKETCLOTH151
78850-120-72FRESHMAKER ANTISEPTIC WET WIPES72 in 1 PACKETCLOTH721
78850-120-72FRESHMAKER ANTISEPTIC WET WIPES3.6 g in 1 PACKAGECLOTH3.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78850-120FRESHMAKER ANTISEPTIC WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI]1Legacy NDC, 6 package rows20200722_1cbcd01d-604e-4916-9660-82a6b5fe05e5.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78850-12078850-120-15, 78850-120-72, 78850-120-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BENZOIC ACID8SKN0B0MIMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DEHYDROACETIC ACID2KAG279R6RIACT
GLYCERINPDC6A3C0OXIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT

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
a8d55210-407d-442b-b373-29c9ff4ffd1f1cbcd01d-604e-4916-9660-82a6b5fe05e52020-07-15WarningsExact identifier
spl id: a8d55210-407d-442b-b373-29c9ff4ffd1f
spl set id: 1cbcd01d-604e-4916-9660-82a6b5fe05e5

Reported adverse events (FAERS/openFDA)#

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