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Drug Facts
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
QUESTIONS? 1-888-423-0139 [email protected]
www.topcarebrand.com
Topcare Sensitive Paste, Dentifrice
FDA Label NDC 36800-451
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Assoc. Llc for the product Topcare Sensitive (NDC 36800-451). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
* Please review the disclaimer below.
