Label: COMPLETE CARE TARTAR CONTROL PLUS WHITENING BAKING SODA AND PEROXIDE- sodium fluoride paste, dentifrice
- NDC Code(s): 10237-653-60, 10237-653-72
- 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 November 8, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions do not swallow supervise children as necessary until capable of using without supervision
rinse away toothpaste residue throughly after brushingadults 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
- QUESTIONS
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INGREDIENTS AND APPEARANCE
COMPLETE CARE TARTAR CONTROL PLUS WHITENING BAKING SODA AND PEROXIDE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-653 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLOXALENE (UNII: V8B3K56SW0) SODIUM PERCARBONATE (UNII: Z7G82NV92P) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) 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:10237-653-60 1 in 1 CARTON 05/01/2012 11/01/2024 1 170 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-653-72 1 in 1 CARTON 05/01/2012 09/29/2019 2 204 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 01/29/2012 11/01/2024 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-653)