FDA Label for Opalescence Sensitivity Relief Whitening
View Indications, Usage & Precautions
Opalescence Sensitivity Relief Whitening Product Label
The following document was submitted to the FDA by the labeler of this product Ultradent Products, Inc.. 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.
Other
Drug Facts
Manufactured by: Ultradent Products, Inc., South Jordan, UT 84095, USA
Otc - Purpose
| Active Ingredients | Purpose |
|---|---|
| Potassium Nitrate 5% w/w | Antihypersensitivity |
| Sodium Fluoride 0.25% w/w | Anticavity |
Uses
- Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
- Aids in the prevention of dental cavities.
Warnings
Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth.
- Children under 12 years of age: Consult a dentist or doctor.
Other Information
- Do not use if tamper-evident seal is broken
- Store at room temperature
- Contains FD&C Yellow No. 5 (tartrazine) as a color additive
Inactive Ingredients
Water (Aqua), Silica, Xylitol, Glycerin, Sorbitol, Flavor (Aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)
Questions Or Comments
Call toll-free 1.800.552.5512
Principal Display Panel - 133 G Tube Carton
Opalescence™
whitening toothpaste
Cool Mint
Sensitivity
Relief
NET WT. 4.7 oz • 133 g • 100 ml
FLUORIDE TOOTHPASTE
FOR SENSITIVE TEETH
* Please review the disclaimer below.