FDA.reportPublic FDA data

Softie SOFT AND SMOOTH HANDSOAP ANTIBACTERIAL White Tea

Manufacturer
COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2021-01-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:46

Label at a glance#

ProductSoftie SOFT AND SMOOTH HANDSOAP ANTIBACTERIAL White Tea
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Pump into hands, lather vigorously for at least 15 seconds, rinse and dry thoroughly.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

• For handwashing to decrease bacteria on the skin

WARNINGS: FOR EXTERNAL USE ONLY.

WARNINGS SECTION

Avoid contact with eyes, if eye contact occurs, flush with water.

Stop use and ask a doctor if irritation and redness develops.

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

Pump into hands, lather vigorously for at least 15 seconds, rinse and dry thoroughly.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Coco-Glucoside (and) Glyceryl Oleate, Cocamide DEA (and) Glycerin, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Parfum, Citronellol, Linalool.

SPL UNCLASSIFIED SECTION

New!

Softsoap® is a registered trademark of Colgate-Palmolive Co. which has not manufactured, distributed or sponsored this product.

FDA APPROVED

Designed & Developed
By: Primax USA LLC
Brooklyn, NY 11204

MADE IN TURKEY

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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
74955-054-012023-01-30C16284748780-1f386c64a-120f-0266-e053-dadaa90a7c1aSoftie Soap ® SOFT & SMOOTH HAND SOAP ANTIBACTERIAL White Tea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74955-054-01Softie SOFT AND SMOOTH HANDSOAP ANTIBACTERIAL White Tea400 mL in 1 BOTTLE, PUMPLIQUID4001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74955-054SOFTIE SOFT AND SMOOTH HANDSOAP ANTIBACTERIAL WHITE TEA (BENZALKONIUM CHLORIDE) LIQUID [COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 1 package rows20210204_f9d1d6d5-ece5-4059-bfb4-e1dcec378c00.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74955-05474955-054-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERYL OLEATE4PC054V79PIACT
COCO DIETHANOLAMIDE92005F972DIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LINALOOL, (+/-)-D81QY6I88EIACT

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
859444b8-b4b7-4b63-a218-8431ceace5f8f9d1d6d5-ece5-4059-bfb4-e1dcec378c002021-01-26WarningsExact identifier
spl id: 859444b8-b4b7-4b63-a218-8431ceace5f8
spl set id: f9d1d6d5-ece5-4059-bfb4-e1dcec378c00

Reported adverse events (FAERS/openFDA)#

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