FDA.reportPublic FDA data

Creamol Antibacterial Wet Wipes 10pcs

Manufacturer
Laber Kimya AR-GE Sanayi Ticaret-Levent KAHRIMAN | Laber Kimya AR-GE Sanayi Ticaret Levent KAHRIMAN
Effective date
2020-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:58

Label at a glance#

ProductCreamol Antibacterial Wet Wipes 10pcs
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Wipe hands; discard

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(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride (Quaternary ammonium compounds, benzyl (C12-16) alkyldimethyl, chlorides) %0,13 (w/w). Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer Wet Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

· in children less than 2 months of age

· on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

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

Wipe hands; discard

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

Aqua, Glycerin, Phenoxyethanol, Polysorbate 20, Sodium PCA, Tetrasodium EDTA, Ethylhexylglycerin, Citric acid

Package Panel- Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77892-021-0177892-021-01

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77892-021-012022-01-28C16284748780-1d6a99b39-ff99-a426-e053-dadaa90af4c2Creamol Antibacterial Wet Wipes-10 pcs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77892-021-01Creamol Antibacterial Wet Wipes 10pcs4 g in 1 POUCHSWAB41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77892-021CREAMOL ANTIBACTERIAL WET WIPES 10PCS (BENZALKONIUM CHLORIDE) SWAB [LABER KIMYA AR-GE SANAYI TICARET-LEVENT KAHRIMAN]1Legacy NDC, 1 package rows20201120_b470389a-386a-502e-e053-2995a90afc01.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
77892-02177892-021-01

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
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
b470389a-386b-502e-e053-2995a90afc01b470389a-386a-502e-e053-2995a90afc012020-11-19WarningsExact identifier
spl id: b470389a-386b-502e-e053-2995a90afc01
spl set id: b470389a-386a-502e-e053-2995a90afc01

Reported adverse events (FAERS/openFDA)#

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