COVEX ANTIBACTERIAL BAR COOL PROTECTION- benzalkonium chloride soap
DALAN KIMYA ENDUSTRI ANONIM SIRKETI

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Covex Antibacterial Bar Soap, Cool Protection

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

for handwashing to decrease bacteria on the skin

Warnings

For external use only

When using this product

Do not use in the eyes.

Stop use and ask a doctor if

irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

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

Directions

Wet hands and forearms. Apply to hands and foreams. Scrub thoroughly for 60 seconds. Rinse and repeat

Inactive ingredients:

Sodium Tallowate, Sodium palmate, Water, Sodium Palm Kernelate, Fragrance, Sodium Chloride, Glycerin, C 12-15 Alkyl Lactate, Titanium Dioxide, Tetrasodium EDTA, Etidronic Acid, Disodium Distrylbiphenyl Disulfonate, Linalool, Limonene, Geraniol, Citral.

Package Labeling:

Updated Cool Wrapper Updated Cool Box

COVEX ANTIBACTERIAL BAR COOL PROTECTION
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51209-018
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ZINC OXIDE (UNII: SOI2LOH54Z)
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)
SODIUM PALMATE (UNII: S0A6004K3Z)
WATER (UNII: 059QF0KO0R)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE SODIUM (UNII: MP1J8420LU)
ETIDRONIC ACID (UNII: M2F465ROXU)
DISODIUM DISTYRYLBIPHENYL DISULFONATE (UNII: 81G7704MYR)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GERANIOL (UNII: L837108USY)
CITRAL (UNII: T7EU0O9VPP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51209-018-00	3 in 1 PACKAGE	06/24/2020
1		115 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/23/2020

Labeler - DALAN KIMYA ENDUSTRI ANONIM SIRKETI (566219285)