FDA.reportPublic FDA data

BREEZE ANTIBACTERIAL HANDSOAP PINK ORCHID AND COCONUT

Manufacturer
COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-10-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:50

Label at a glance#

ProductBREEZE ANTIBACTERIAL HANDSOAP PINK ORCHID AND 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 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

• For handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

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 develops.

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

Styrene/Acrylates Copolymer Aqua, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, DMDM Hydantoin, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA.

SPL UNCLASSIFIED SECTION

Extra Soft

CLEANSING

MOISTURIZING

REFRESHING

UNAC GROUP KOZMETİK SAN. TİC. LTD. ŞTİ

Trump Towers Residence No: 12/238 D.No:606 Şişli, 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

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
74955-030-012025-01-30C16284748780-12cef2736-69d1-d83d-e063-dadaa90ab31fBreeze ANTIBACTERIAL hand soap PINK ORCHID COCONUT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74955-030-01BREEZE ANTIBACTERIAL HANDSOAP PINK ORCHID AND COCONUT500 mL in 1 BOTTLE, PUMPLIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74955-030BREEZE ANTIBACTERIAL HANDSOAP PINK ORCHID AND COCONUT (BENZALKONIUM CHLORIDE) LIQUID [COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 1 package rows20201105_31ccfb07-3b24-409d-bdc1-eafa3351cf1d.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74955-03074955-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
WATER059QF0KO0RIACT
SULISOBENZONE1W6L629B4KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO DIETHANOLAMIDE92005F972DIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DMDM HYDANTOINBYR0546TOWIACT
GLYCERINPDC6A3C0OXIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
EDETATE SODIUMMP1J8420LUIACT

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
acdb4d73-9829-4459-aa13-e4069102548c31ccfb07-3b24-409d-bdc1-eafa3351cf1d2020-10-22WarningsExact identifier
spl id: acdb4d73-9829-4459-aa13-e4069102548c
spl set id: 31ccfb07-3b24-409d-bdc1-eafa3351cf1d

Reported adverse events (FAERS/openFDA)#

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