FDA.reportPublic FDA data

Breeze ANTIBACTERIAL handsoap PINK ORCHID COCONUT

Manufacturer
COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:50

Label at a glance#

ProductBreeze ANTIBACTERIAL handsoap PINK ORCHID COCONUT
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

• Pump into hands, wet as needed • Lather vigorously for at least 15 seconds • Wash skin, rinse thoroughly and dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.20%

Purpose

OTC - PURPOSE SECTION

Antibacterial

INDICATIONS & USAGE SECTION

Use • For handwashing to decrease bacteria on the skin

WARNINGS SECTION

Warnings For external use only

When using this product • Avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.

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

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

• Pump into hands, wet as needed

• Lather vigorously for at least 15 seconds

• Wash skin, rinse thoroughly and dry

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Cocoamidopropyl Betaine, Coco Glucoside, Glyceryl Oleate, Cocoamide DEA, Sodium Laureth Sulphate, Laureth-7 Citrate, Tocopheryl Acetate (Vit E), Sodium Chloride, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Parfume, Benzyl Alcohol, Benzyl Benzoate, Coumarin

SPL UNCLASSIFIED SECTION

Extra Soft

CLEANSING

MOISTURIZING

REFRESHING

UNAC GROUP KOZMETIK SAN. TIC LTD. STI

Trump Towers Residence No: 12/238 D. No:606 Sisli, Istanbul- TURKEY - Tel: +90 212 526 68 69 www.unac.com.tr

USA DISTRIBUTOR: UNAC INTERNATIONAL INC. / info@unacusa.com

Made in TURKEY

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1439778benzalkonium chloride 0.2 % Medicated Liquid SoapPSN1
1439778benzalkonium chloride 2 MG/ML Medicated Liquid SoapSCD1
1439778benzalkonium chloride 0.2 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74955-023-012023-01-30C16284748780-1f386c64a-3088-0266-e053-dadaa90a7c1aBreeze ANTIBACTERIAL handsoap PINK ORCHID COCONUT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74955-023-01Breeze ANTIBACTERIAL handsoap PINK ORCHID COCONUT500 mL in 1 BOTTLE, PUMPLIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74955-023BREEZE ANTIBACTERIAL HANDSOAP PINK ORCHID COCONUT (BENZALKONIUM CHLORIDE) LIQUID [COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 1 package rows20200826_b6263d90-a3f2-4ad5-95ab-4200d5623796.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74955-02374955-023-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERYL OLEATE4PC054V79PIACT
COCO DIETHANOLAMIDE92005F972DIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
LAURETH-7Z95S6G8201IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZYL BENZOATEN863NB338GIACT
COUMARINA4VZ22K1WTIACT

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
47a6aadd-ffed-47f9-a6ac-b5f0076b9e09b6263d90-a3f2-4ad5-95ab-4200d56237962020-08-13WarningsExact identifier
spl id: 47a6aadd-ffed-47f9-a6ac-b5f0076b9e09
spl set id: b6263d90-a3f2-4ad5-95ab-4200d5623796

Reported adverse events (FAERS/openFDA)#

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