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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 Enamel Guard Sensitive Paste, Dentifrice
FDA Label NDC 21130-350
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 Enamel Guard Sensitive (NDC 21130-350). 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 0.15% w/v fluoride ion
Otc - Purpose
Purpose
Antihypersensitivity
Anticavity
Indications & Usage
Uses
- aids in the prevention of dental cavities
- aids in reducing sensitivity
Warnings
Warnings
Otc - When Using
If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
Otc - Stop Use
Stop use and ask a 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 a doctor
Inactive Ingredient
Inactive ingredients water, hydrated silica, sorbitol,glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide
Storage And Handling
Store in a cool dry place
Package Label.Principal Display Panel
ALPINE MINT FLAVOR
Signature Care™ Enamel Guard
Gentle Whitening
DAILY ANTICAVITY TOOTHPASTE WITH FLUORIDE
HELPS HARDEN TOOTH ENAMEL WITH ACID PROTECTION FORMULA
NET WT 4 OZ (113 g)
* Please review the disclaimer below.
