FDA Label for Topcare Sensitive Extra Whitening
View Indications, Usage & Precautions
Topcare Sensitive Extra Whitening Product Label
The following document was submitted to the FDA by the labeler of this product Topco Assoc. 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.
Other
Drug Facts
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
QUESTIONS? 1-888-423-0139 [email protected]
www.topcarebrand.com
Otc - Active Ingredient
Active ingredients
Potassium nitrate 5%
Sodium fluoride 0.24% (0.15% w/v fluoride ion)
Otc - Purpose
Purpose
Antihypersensitivity
Anticavity
Indications & Usage
Uses
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
- aids in the prevention of dental cavities
Warnings
Warnings
Otc - When Using
​When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.
Otc - Stop Use
See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Adults and children 12 years of age and older: Apply at least 1-inch strip of the product onto a soft bristle toothbrush.
- Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.
- Children under 12 years of age: Consult a dentist or physician.
Storage And Handling
Other information
Store in a cool dry place. Keep tube capped when not in use.
Inactive Ingredient
Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum
Package Label.Principal Display Panel
TopCare® everyday™
MAXIMUM STRENGTH
Sensitive
ANTICAVITY TOOTHPASTE FOR SENSITIVE TEETH
EXTRA WHITENING
NET WT 4 OZ (113 g)
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