CEPACOL  ANTIBACTERIAL- cetylpyridinium chloride liquid 
RB Health (US) 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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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

PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label
CEPACOL   ANTIBACTERIAL
cetylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-790
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetylpyridinium chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium chloride0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-790-801 in 1 CARTON06/22/2011
1710 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/22/2011
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2019
Document Id: d7dd27f1-a31a-45ee-9dfa-0f6b2d2567cf
Set id: 7c19eba6-3ebd-497f-9066-6152b72eafdd
Version: 4
Effective Time: 20191223
 
RB Health (US) LLC