Cēpacol ®

Cēpacol ®
SPL v8
SPL
SPL Set ID 7c19eba6-3ebd-497f-9066-6152b72eafdd
Route
ORAL
Published
Effective Date 2022-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.05 g)
Inactive Ingredients
Water Alcohol Glycerin Sodium Phosphate, Dibasic, Unspecified Form Eucalyptus Oil Polysorbate 80 Methyl Salicylate Cinnamon Oil Peppermint Oil Saccharin Sodium Sodium Phosphate, Monobasic, Anhydrous Menthol, Unspecified Form Edetate Disodium Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-06-22 Until 2027-09-03

Description

Drug Facts

Purpose

Antigingivitis/Antiplaque


Medication Information

Purpose

Antigingivitis/Antiplaque

Description

Drug Facts

Uses

helps prevent and reduce plaque that leads to:

  • gingivitis, an early form of gum disease
  • bleeding gums
Section 42229-5

Drug Facts

Section 50565-1

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.
Questions?

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

Active Ingredient

Cetylpyridinium chloride 0.05%

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

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.
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


Structured Label Content

Uses

helps prevent and reduce plaque that leads to:

  • gingivitis, an early form of gum disease
  • bleeding gums
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Antigingivitis/Antiplaque

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.
Questions?

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

Active Ingredient (Active ingredient)

Cetylpyridinium chloride 0.05%

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 (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

Stop Use and Ask A Dentist If (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.
Principal Display Panel 710 Ml Bottle Label (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


Advanced Ingredient Data


Raw Label Data

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