Therabreath Plaque Control Rinse
FDA Label NDC 10237-259

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Therabreath Plaque Control (NDC 10237-259). 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

Active Ingredient

Cetylpyridinium Chloride 0.075%

Purpose

Antigingivitis/Antiplaque

Uses

  • Helps prevent gingivitis, an early form of gum disease and bleeding gums
  • Helps control plaque that leads to gingivitis and 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 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 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 and olderVigorously swish 20 milliliters (4 teaspoonfuls) 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 yearsSupervise use.
Children under 6 yearsDo not use.

Other Information

This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

Water, Glycerin, Poloxamer 407, Flavor, Sodium Benzoate, Sucralose

Principal Display Panel - 473 Ml Bottle Label

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

WITH
50% MORE
CPC‡

TheraBreath™

DENTIST FORMULATED

PLAQUE CONTROL

PRE-BRUSH

ORAL RINSE

HELPS FIGHT PLAQUE & GINGIVITIS FOR 24 HOURS*

ANTI-BACTERIAL RINSE • CLEANS WHOLE MOUTH

No Alcohol • No Dyes • Non Burning

COOL MINT

16 fl. oz.
473 mL

Principal Display Panel (473 mL Bottle Label)

Principal Display Panel (473 mL Bottle Label)

* Please review the disclaimer below.