BREEZE ANTIBACTERIAL HANDSOAP CHAMOMILE AND ALOE VERA- benzalkonium chloride liquid

BREEZE ANTIBACTERIAL HANDSOAP CHAMOMILE AND ALOE VERA by

Drug Labeling and Warnings

BREEZE ANTIBACTERIAL HANDSOAP CHAMOMILE AND ALOE VERA 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

Use

For handwashing to decrease bacteria on the skin

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 develops.

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, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, DMDM Hydantoin, FD&C Yellow No:5, FD&C Blue No.1, 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

INGREDIENTS AND APPEARANCE

BREEZE ANTIBACTERIAL HANDSOAP CHAMOMILE AND ALOE VERA 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74955-032
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74955-032-01	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	part333E	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(74955-032)