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Drug Facts
Therabreath Plaque Control Rinse
FDA Label NDC 10237-259
11 label sections · Submitted to the FDA by Church & Dwight Co., Inc. · 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, warnings, stop use and ask a dentist if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Cetylpyridinium Chloride 0.075%
Purpose
Antigingivitis/Antiplaque
Uses
- helps prevent • gingivitis, an early form of gum disease • bleeding gums
- helps control plaque that leads to • gingivitis • bleeding gums
Warnings
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 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 older | vigorously 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 years | supervise use. |
| children under 6 years | do 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
USE BEFORE BRUSHING
ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE
TheraBreath ™
DENTIST FORMULATED
PLAQUE CONTROL
PRE-BRUSH
ORAL RINSE
HELPS FIGHT PLAQUE & GINGIVITIS FOR 12 HOURS*
Helps reduce gingivitis, an early form of gum disease
ANTI-BACTERIAL RINSE • CLEANS WHOLE MOUTH
No Alcohol • No Dyes • Non Burning
REFRESHING MINT
16 fl. oz.
473 mL
*As part of an oral care routine.
* Please review the disclaimer below.
