CEPACOL ANTIBACTERIAL - cetylpyridinium chloride liquid
Reckitt Benckiser LLC

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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Drug Facts

Active ingredient

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis/Antiplaque

Uses

helps prevent and reduce plaque that leads to:

gingivitis, an early form of gum disease
bleeding gums

Warnings

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks
you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of the reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse
children 6 years to under 12 years of age: supervise use
children under 6 years of age: do not use.

Other Information

this rinse is not intended to replace brushing or flossing
store at room temperature 20-25°C (68-77°F)
protect from humidity

Inactive ingredients

purified water, alcohol 14% v/v, glycerin, sodium phosphate dibasic, eucalyptus oil, polysorbate 80, methyl salicylate, cinnamon oil, peppermint oil, saccharin sodium, sodium phosphate monobasic anhydrous, menthol, edetate disodium, FD&C Yellow #5

Questions?

1-888-963-3382 You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label

NDC 63824-790-80

Cēpacol®

ANTIBACTERIAL*
MULTI-PROTECTION MOUTHWASH

CPC–Antigingivitis/Antiplaque Oral Rinse

*Kills Germs That Cause Bad Breath

Reduces Plaque
Freshens Breath

#1 BRAND IN HOSPITALS

TO OPEN: Squeeze both raised finger pads
on cap and continue to squeeze while turning.

TO CLOSE: Turn cap until it locks completely.

24 FL. OZ. (710 mL)

0336220
062111

PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label

CEPACOL ANTIBACTERIAL
cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-790
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetylpyridinium chloride (Cetylpyridinium)	Cetylpyridinium chloride	0.05 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
ALCOHOL
GLYCERIN
SODIUM PHOSPHATE, DIBASIC
EUCALYPTUS OIL
POLYSORBATE 80
METHYL SALICYLATE
CINNAMON OIL
PEPPERMINT OIL
SACCHARIN SODIUM
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
MENTHOL
EDETATE DISODIUM
FD&C YELLOW NO. 5

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:63824-790-80	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		710 mL in 1 BOTTLE	This package is contained within the CARTON (63824-790-80)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	06/22/2011

Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2011 Reckitt Benckiser LLC