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
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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)
