FDA Label for Therabreath Healthy Gums Oral Rinse
View Indications, Usage & Precautions
Therabreath Healthy Gums Oral Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Dr. Harold Katz, 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.
Active Ingredient
Cetylpyridinium chloride 0.05%
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.
