BREEZE ANTIBACTERIAL WET WIPES 60 PCS- benzalkonium chloride cloth

BREEZE ANTIBACTERIAL WET WIPES 60 PCS by

Drug Labeling and Warnings

BREEZE ANTIBACTERIAL WET WIPES 60 PCS by is a Otc medication manufactured, distributed, or labeled by COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

INDICATIONS & USAGE

Use  Decreases bacteria on skin

Warnings

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.

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

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

Directions for Use

Thoroughly wipe hands and face as desired.

Allow to dry without wiping.

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

Inactive Ingredients

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

EN- PLEASE READ THE LABEL BEFORE USING.

Commercial name of the product: Antibacterial and Antifungal Wet Wipes

Formulation form: Solid (Solution Absorbed Wipe)

Structure of Cloth: Nonwoven (Nonwoven fabric)

Warnings: Under normal conditions, its shelf life is 2 years.

Use the opened product within 6 months.

Keep out of reach of children and store in a cool dry place.

Avoid direct sunlight and eye contact.

Name and amount of the active substance

(%) 50 conc. Alkyl (C12-C16) dimethyl benzyl ammonium chloride

(%) 1 w /w Net ratio: 0.5%

*** Amounts of active ingredient absorbed in wipe are given in the table.

CAS NO: 68424-85-1

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.

HARMFUL ORGANISMS TO BE USED

MICROORGANISMS WHICH THE PRODUCT IS EFFECTIVE	USAGE	DOSE / RANGE OF USE
S.aureus ATCC 6538; P.aeruginosa ATCC 15442; E.coli ATCC 10536: E.hirae ATCC 10541 C.albicans ATCC 10231; Aspergillus brasiliensis ATCC 16404	Antibacterial and Antifungal Wet Wipes: It is used as wiping in the cleaning of bacteria and fungi in the hands. No rinsing is required.	The number of wet wipes used to wipe the hands, arms and  desired area is 1.	WHEN NEEDED

                                                                                                                                                 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

INGREDIENTS AND APPEARANCE

BREEZE ANTIBACTERIAL WET WIPES 60 PCS 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74955-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
BENZOIC ACID (UNII: 8SKN0B0MIM)
EDETATE SODIUM (UNII: MP1J8420LU)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74955-021-01	60 in 1 PACKAGE	01/01/2020
1		4.23 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 74955-021-02	60 in 1 PACKAGE	01/01/2020
2		4.23 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2020

Labeler - COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (595671824)

Establishment
Name	Address	ID/FEI	Business Operations
COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI		595671824	manufacture(74955-021)