Label: SIGNATURE CARE SENSITIVE MAXIMUM STRENGTH- potassium nitrate, sodium fluoride paste, dentifrice
- NDC Code(s): 21130-351-19, 21130-351-20
- Packager: Safeway
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 12, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIGNATURE CARE SENSITIVE MAXIMUM STRENGTH
potassium nitrate, sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-351 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.15 g in 100 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) HYDRATED SILICA (UNII: Y6O7T4G8P9) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-351-19 1 in 1 CARTON 03/02/2019 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:21130-351-20 2 in 1 PACKAGE 03/02/2019 2 1 in 1 CARTON 2 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 03/02/2019 Labeler - Safeway (009137209) Registrant - Lornamead Inc. (080046418) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(21130-351)
