Label: ADVANCE WHITE TARTAR CONTROL BREATH FRESHENING- sodium fluoride paste, dentifrice
- NDC Code(s): 10237-656-09, 10237-656-43, 10237-656-60, 10237-656-72
- 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 January 18, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions do not swallow supervise children as necessary until capable of using without supervision
adults and children 2 years and older brush teeth throughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years instruct in good rushing and rinsing habits (to minimize swallowing)
children under 2 years consult a dentist or physician - INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ADVANCE WHITE TARTAR CONTROL BREATH FRESHENING
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-656 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 WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:10237-656-09 1 in 1 CARTON 01/29/2019 09/23/2019 1 25 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-656-43 1 in 1 CARTON 01/29/2012 09/23/2019 2 121 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:10237-656-60 1 in 1 CARTON 09/23/2019 3 170 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:10237-656-72 1 in 1 CARTON 01/29/2012 09/23/2019 4 204 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 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-656)