FDA.reportPublic FDA data

Breeze ANTIBACTERIAL handsoap CHAMOMILE ALOE VERA

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 23:25:44

Label at a glance#

ProductBreeze ANTIBACTERIAL handsoap CHAMOMILE ALOE VERA
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, Fragrance, Coumarin, Hexyl Cinnamal, Hydroxycitronellal, D-Limonene, Linalool, CI 42090, CI 19140

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74955-025-032023-01-30C16284748780-1f386c64a-4296-0266-e053-dadaa90a7c1aBreeze ANTIBACTERIAL handsoap CHAMOMILE ALOE VERA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74955-025-03Breeze ANTIBACTERIAL handsoap CHAMOMILE ALOE VERA500 mL in 1 BOTTLE, PUMPLIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74955-025BREEZE ANTIBACTERIAL HANDSOAP CHAMOMILE ALOE VERA (BENZALKONIUM CHLORIDE) LIQUID [COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 1 package rows20200826_0d807c65-1b3b-4fa7-bd6f-6111d3bb034e.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74955-02574955-025-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
COUMARINA4VZ22K1WTIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
90416fea-3904-4012-9332-1a16a29003e00d807c65-1b3b-4fa7-bd6f-6111d3bb034e2020-08-13WarningsExact identifier
spl id: 90416fea-3904-4012-9332-1a16a29003e0
spl set id: 0d807c65-1b3b-4fa7-bd6f-6111d3bb034e

Reported adverse events (FAERS/openFDA)#

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