DEX- benzalkonium chloride liquid

Dex by

Drug Labeling and Warnings

Dex by is a Otc medication manufactured, distributed, or labeled by TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride %0.13....Purpose: Antibacterial

Purpose

Antibacterial, Liquid Soap

Use

It helps eliminate bacteria on hands.

Warnings

For external use only. When using this product, avoid contact with eyes. In case of contact, flush with water.

Do not use

If swallowed, get medical help or contact a Poison Control Center right away.

WHEN USING

When using this product, avoid contact with eyes. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• wash hands and rinse

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Aqua, Lauramine Oxide, Cetrimonium Chloride, Glycerin, PEG - 150 Distearate, Fragrance, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1(CI 42051)

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

DEX 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76964-300
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
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)	8 g  in 100 g
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)	3 g  in 100 g
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)	0.4 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 100 g
WATER (UNII: 059QF0KO0R)	84.37 g  in 100 g
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)	2 g  in 100 g
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)	0.1 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76964-300-01	500 g in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2020

Labeler - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)

Registrant - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)

Establishment
Name	Address	ID/FEI	Business Operations
TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI		535142780	manufacture(76964-300)