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  5. Label Information: Cepacol Antibacterial

FDA Label for Cepacol Antibacterial

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. STOP USE AND ASK A DENTIST IF
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?
    11. PRINCIPAL DISPLAY PANEL - 710 ML BOTTLE LABEL

Cepacol Antibacterial Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


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

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.

Otc - Keep Out Of Reach Of Children



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.


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

* Please review the disclaimer below.