ANTIBACTERIAL HANDWASH TROPICAL BEACH- benzalkonium chloride liquid

ANTIBACTERIAL HANDWASH by

Drug Labeling and Warnings

ANTIBACTERIAL HANDWASH by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Hobi Kozmetik Imalat Sanayi Ve Ticaret Anonim Sirketi. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

USES

for hand washing to decrease bacteria on the skin.

Warning:

Avoid contact with eyes. In case of contact flush with water. Keep out of direct sunlight. Do not drink, not edible. External use only.

Keep out of reach of children.

Directions

Pump a small amount of soap into wet hands, rub hands together to create rich lather, then rinse.

Ingredients:

Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Cocamide MIPA, Laureth-4, Glycerin*, Polyquaternium-7*, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Citric Acid, Benzophenono-4, Tocopheryl Acetate, FD&C Blue No. 1, D&C Red No. 33

*Contains one or more of these ingredients.

SPL UNCLASSIFIED SECTION

Kill Germs and Odors

Distributed By:
Universal Distribution Center
96 Distribution Boulevard,
Edison, NJ 08817

Made in Turkey

Packaging

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HANDWASH  TROPICAL BEACH
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-043
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)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
LAURETH-4 (UNII: 6HQ855798J)
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-043-01	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2018

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Universal Distribution Center LLC (019180459)

Establishment
Name	Address	ID/FEI	Business Operations
Hobi Kozmetik Imalat Sanayi Ve Ticaret Anonim Sirketi		533139227	manufacture(52000-043)