FDA.reportPublic FDA data

SERATIN

Manufacturer
VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:44

Label at a glance#

ProductSERATIN
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - WHEN USING SECTION

Benzalkonium chloride 0.13 %

OTC - PURPOSE SECTION

Antibacterial

WARNINGS SECTION

For external use only ; only hands

OTC - ACTIVE INGREDIENT SECTION

avoid contact with eyes.If contact occurs , rinse eyes thoroughly with water
antimicrobial

OTC - STOP USE SECTION

  • irritation or redness develops
  • condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

glycerin, sodium laureth sulfate, lauramine oxide, cocamidopropyl betaine, edetate sodium, water, citric acid monohydrate, polyquaternium-7,aloe vera leaf,cocamide, cetrimonium chloride,methylchloroisothiazolinone,styrene/ acrylamide copolymer, fragrance lavender& chia F-153480, alpha-tocopherol acetate, sodium chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SERATIN Antibacterial soap 450 ml backSERATIN Antibacterial soap 450 ml backSERATIN Antibacterial soap 500 mL frontSERATIN Antibacterial soap 500 mL frontSERATIN Antibacterial soap 450 mL frontSERATIN Antibacterial soap 450 mL frontSERATIN Antibacterial soap 500 mL backSERATIN Antibacterial soap 500 mL backSERATIN Antibacterial soap 1000 mL frontSERATIN Antibacterial soap 1000 mL frontSERATIN Antibacterial soap 1000 mL backSERATIN Antibacterial soap 1000 mL back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79652-011-012022-01-28C16284748780-1d6a99b39-febc-a426-e053-dadaa90af4c2b3134fe3-5a8a-1c1b-e053-2a95a90a5fef
79652-011-022022-01-28C16284748780-1d6a99b39-febc-a426-e053-dadaa90af4c2b3134fe3-5a8a-1c1b-e053-2a95a90a5fef
79652-011-032022-01-28C16284748780-1d6a99b39-febc-a426-e053-dadaa90af4c2b3134fe3-5a8a-1c1b-e053-2a95a90a5fef

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79652-011-01SERATIN450 mL in 1 BOTTLE, PLASTICSOAP4501
79652-011-02SERATIN500 mL in 1 BOTTLE, PLASTICSOAP5001
79652-011-03SERATIN1000 mL in 1 BOTTLE, PLASTICSOAP10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79652-011SERATIN (VERNEL KOZMETIK) SOAP [VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 3 package rows20201102_b3134fe3-5a8a-1c1b-e053-2a95a90a5fef.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79652-01179652-011-01, 79652-011-02, 79652-011-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDE3YXD33R71GIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT

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
b3134fe3-5a8b-1c1b-e053-2a95a90a5fefb3134fe3-5a8a-1c1b-e053-2a95a90a5fef2020-11-01WarningsExact identifier
spl id: b3134fe3-5a8b-1c1b-e053-2a95a90a5fef
spl set id: b3134fe3-5a8a-1c1b-e053-2a95a90a5fef

Reported adverse events (FAERS/openFDA)#

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