BREEZE ANTIBACTERIAL HANDSOAP BERRY MIXTURE- benzalkonium chloride liquid

Breeze ANTIBACTERIAL handsoap BERRY MIXTURE by

Drug Labeling and Warnings

Breeze ANTIBACTERIAL handsoap BERRY MIXTURE 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 0.20%

Purpose

Antibacterial

INDICATIONS & USAGE

Use For handwashing to decrease bacteria on the skin

WARNINGS

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pump into hands, wet as needed

Lather vigorously for at least 15 seconds

Wash skin, rinse thoroughly and dry

Inactive Ingredients

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, Citronellol, Geraniol, Hexyl Cinnamal, D-Limonene, Linalool, CI 16035

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

INGREDIENTS AND APPEARANCE

BREEZE ANTIBACTERIAL HANDSOAP BERRY MIXTURE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74955-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
LAURETH-7 (UNII: Z95S6G8201)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74955-026-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020

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(74955-026)