Label: HEB ENAMEL PROTECTION MULTI ACTION- potassium nitrate, sodium fluoride paste, dentifrice
- NDC Code(s): 37808-336-19
- Packager: HEB
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 17, 2025
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- 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) or as recommended by a dentist or physican
- Make sure to brush all sensitive areas of the teeth
- Do not swallow
Children under 12 years of age: consult a dentist or a doctor
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEB ENAMEL PROTECTION MULTI ACTION
potassium nitrate, sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-336 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) 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) MICA (UNII: V8A1AW0880) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-336-19 1 in 1 CARTON 02/20/2019 1 113 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 02/20/2019 Labeler - HEB (007924756) Registrant - Lornamead Inc. (080046418) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(37808-336)