Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose Antihypersensitivity Anticavity
TopCare Sensitive
- Manufacturer
- TOPCO Assoc. LLC | Lornamead Products
- Effective date
- 2026-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 14
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:51:54
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
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 SECTION
Warnings
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
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.
Other Label Information
STORAGE AND HANDLING SECTION
Other information Store in a cool dry place. Keep tube capped when not in use.
INACTIVE INGREDIENT SECTION
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
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | PSN | 14 |
| 1038929 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 14 |
| 1038929 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 14 |
| 1038929 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 14 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 14 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 14 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | SY | 14 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-451-59 | TopCare SensitiveExtra Whitening | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 14 | |
| 36800-451-59 | TopCare SensitiveExtra Whitening | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 14 |
Products#
- TopCare Sensitive Extra Whitening
- Potassium nitrate, Sodium fluoride
- FLUORIDE ION
- NITRATE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-451 | 36800-451-59 |
Ingredients#
Complete SPL Sections#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose Antihypersensitivity Anticavity
INDICATIONS & USAGE SECTION
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 SECTION
Warnings
DOSAGE & ADMINISTRATION SECTION
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 SECTION
Other information Store in a cool dry place. Keep tube capped when not in use.
INACTIVE INGREDIENT SECTION
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
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 13 | 2025-08-08 | full-release | 2026-06-01 01:09:57 |