Label: COMPLETE CARE WHOLE MOUTH PROTECTION- sodium fluoride paste, dentifrice
- NDC Code(s): 10237-675-09, 10237-675-12, 10237-675-60
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 25, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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Directions
Directions do not swallow • supervise children as necessary until capable of using without supervision • rinse away toothpaste residue throughly after brushing
adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician - INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
COMPLETE CARE WHOLE MOUTH PROTECTION
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-675 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) HYDRATED SILICA (UNII: Y6O7T4G8P9) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color white Score Shape Size Flavor MINT (Fresh Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-675-60 1 in 1 CARTON 12/31/2021 1 170 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-675-09 1 in 1 CARTON 12/31/2021 2 25.5 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:10237-675-12 1 in 1 CARTON 12/31/2021 3 340 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 final part355 12/31/2021 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-675)