Active Ingredient
Cetylpyridinium chloride 0.05%
Therabreath Healthy Gums Oral Rinse
FDA Label NDC 72551-247
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Harold Katz, Llc for the product Therabreath Healthy Gums Oral Rinse (NDC 72551-247). 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 active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, therabreath healthy gums oral rinse, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigingivitis/Antiplaque
Uses
•Helps prevent gingivitis, an early form of gum disease and bleeding gum
•Helps control plaque that leads to gingivitis and bleeding gums
Warnings
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.
Stop Use and Ask a Doctor 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 or symptoms of periodontitis, a serious form of gum disease.
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 under12 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, Sorbitol, Xylitol, PEG-40 Hydrogenated Castor Oil, Flavor, Citric Acid, Sodium Hydroxide, Sodium Bicarbonate,
Zinc Gluconate, Sodium Chlorite, Sodium Citrate
* Please review the disclaimer below.
