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Cepacol

Reckitt Benckiser LLC

Cēpacol ANTIBACTERIAL MULTI-PROTECTION MOUTHWASH


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis/Antiplaque

Cepacol 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

Cepacol

Cepacol

Cetylpyridinium chloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-790
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
cetylpyridinium chloride 0.05 g

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 710 in 1 BOTTLE
2 NDC:63824-790-80 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-06-22


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Be sure to consult your doctor before taking any medication!
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