Cepacol Liquid
FDA Label NDC 63824-790

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Cepacol (NDC 63824-790). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, stop use and ask a dentist if, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

  • 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)

    Principal Display Panel (710 mL Bottle Label)

* Please review the disclaimer below.