FDA.reportPublic FDA data

BREEZE ANTIBACTERIAL WET WIPES 60 PCS

Manufacturer
COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-09-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:29:53

Label at a glance#

ProductBREEZE ANTIBACTERIAL WET WIPES 60 PCS
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Thoroughly wipe hands and face as desired. Allow to dry without wiping. Discard wipe in trash receptacle after use. Do not flush.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

INDICATIONS & USAGE SECTION

Use • Decreases bacteria on skin

Warnings

WARNINGS SECTION

For external use only

Keep out of eyes. In case of eye contact, rinse with water.

If irritation develops, discontinue use.

Consult a doctor if irritation persists more than 72 hours.

Use the opened product within 6 months

Avoid direct sunlight

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical attention or contact a Poison Control Center.

Keep out of reach of children, except with adult supervision.

Directions for Use

DOSAGE & ADMINISTRATION SECTION

Thoroughly wipe hands and face as desired.

Allow to dry without wiping.

Discard wipe in trash receptacle after use. Do not flush.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Phenoxyethanol, Perfume, Propylene Glycol, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Benzoic acid, Tetrasodium Edta, Dehydroacetic acid, Glycerin, Tocopheryl Acetate (Vit E), Aloe Barbadensis Leaf Extract (Aloevera), Polysorbate 20, Citric Acid.

SPL UNCLASSIFIED SECTION

soft & gentle

KILLS 99.9% OF GERMS & BACTERIA

• FREE • ALCOHOL

• FREE • PARABEN

IDEAL FOR TRAVELLING

THICK AND SOFT CLOTHS

FRESH SCENT

Vit E & ALOE VERA

BREEZE ANTIBACTERIAL WET WIPES WITH VITAMIN E and ALOE VERA

BREEZE Antibacterial Wet Wipes are perfect for quick clean-ups when soap and water are not available. Use anytime, anywhere.

Convenient Easy to use and carry anytime!

Use to clean up quickly when your soap and water are not available.

Moisturize Soothes and softens dry skin.

Antibacterial Wet Wipes contain soothing Aloe to help moisturize your skin and leave it feeling soft and smooth. Our Wet Wipes are thick and strong to help even the roughest skin.

                                                                                                                                              Antibacterial and Antifungal Wet Wipes
 Net Quantity                                                                                                                                                    60 pcs
 Size of 1 Dry Wipe                                                                                                                                      18 X 15 cms
 Weight of 1 Dry Wipe                                                                                                                              1,21 gr/adet + %10
 Amount of Solution Absorbed Into Wipe                                                                                                    4,23 gr/adet + %10
 Weight of Solution Absorbed Wipe (Solution+Wipe)                                                                                   5,45 gr/adet + %10
 %Solution /  % Wipe                                                                                                                                    % 77.6/22.4
 ***Amount of Active Ingredient Absorbed in Wipes                                                                                   0,0121gr/adet + %10         

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

EAC

MADE IN TURKEY

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74955-021-012025-01-30C16284748780-12cef2736-b598-d83d-e063-dadaa90ab31fBREEZE ANTIBACTERIAL WET WIPES
74955-021-022025-01-30C16284748780-12cef2736-b598-d83d-e063-dadaa90ab31fBREEZE ANTIBACTERIAL WET WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74955-021-01BREEZE ANTIBACTERIAL WET WIPES 60 PCS4.23 g in 1 PATCHCLOTH4.232
74955-021-01BREEZE ANTIBACTERIAL WET WIPES 60 PCS60 in 1 PACKAGECLOTH602
74955-021-02BREEZE ANTIBACTERIAL WET WIPES 60 PCS60 in 1 PACKAGECLOTH602
74955-021-02BREEZE ANTIBACTERIAL WET WIPES 60 PCS4.23 g in 1 PATCHCLOTH4.232

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74955-021BREEZE ANTIBACTERIAL WET WIPES 60 PCS (BENZALKONIUM CHLORIDE) CLOTH [COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]2Legacy NDC, 4 package rows20200922_b0c1fe40-56c5-4159-8f3d-9cf39c71342b.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
74955-02174955-021-01, 74955-021-02

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
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
BENZOIC ACID8SKN0B0MIMIACT
EDETATE SODIUMMP1J8420LUIACT
DEHYDROACETIC ACID2KAG279R6RIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 207T1F30V5YHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
f9746d17-2094-4224-ad83-9ef3a898c271b0c1fe40-56c5-4159-8f3d-9cf39c71342b2020-09-15WarningsExact identifier
spl id: f9746d17-2094-4224-ad83-9ef3a898c271
spl set id: b0c1fe40-56c5-4159-8f3d-9cf39c71342b

Reported adverse events (FAERS/openFDA)#

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