Other
Drug Facts
DISTRIBUTED BY BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929 www.betterlivingbrandsLLC.com
Signature Care Sensitive Paste, Dentifrice
FDA Label NDC 21130-351
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Signature Care Sensitive (NDC 21130-351). 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 - 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 - 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. 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), and not more than 3 times a day, or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
- 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
Signature Care™
MAXIMUM STRENGTH
SENSITIVE TOOTHPASTE WITH FLUORIDE
FOR SENSITIVE TEETH & CAVITY PROTECTION
RELIEVES PAINFUL SENSITIVITY
Extra Whitening
NET WT 4 OZ (113 g)
* Please review the disclaimer below.
