Otc - Active Ingredient
Active ingredients
Potassium nitrate 5%
Sodium fluoride 0.24% (0.15% w/v fluoride ion)
Care One Paste, Dentifrice
FDA Label NDC 41520-582
12 label sections · Submitted to the FDA by American Sales · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Sales for the product Care One (NDC 41520-582). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 oif 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 persists or 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 a 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.
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
Storage And Handling
Store in a cool, dry place. Keep tube capped when not in use.
Other
DISTRIBUTED BY:
American Sales Company
4201 Walden Avenue
Lancaster, NY 14086
Package Label.Principal Display Panel
Carton R9 (Careone Sensitive Ctn Whitening 2821111r9 001)
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