Medication Guide App

Cepacol Antibacterial

Dosage form: liquid
Ingredients: Cetylpyridinium chloride 0.05g in 100mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-790

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.

Cēpacol®
ANTIBACTERIAL
MULTI-PROTECTION MOUTHWASH

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

CEPACOL   ANTIBACTERIAL
cetylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-790
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetylpyridinium chloride (Cetylpyridinium) Cetylpyridinium chloride0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:63824-790-801 BOTTLE in 1 CARTON
1710 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/22/2011
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2013
 
Reckitt Benckiser LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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