Label: SENSITIVE WHITENING WITH BAKING SODA- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 10237-660-09, 10237-660-45 - Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 30, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions do not swallow
adults and children 12 years and older
- apply at least a 1-inch strip of the product onto a soft bristly toothbrush. Brush teeth for at least one minute, preferable after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
children under 12 years
- consult a dentist or physician
- INACTIVE INGREDIENT
- QUESTIONS
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SENSITIVE WHITENING WITH BAKING SODA
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-660 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.43 mg in 1 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score Shape Size Flavor MINT (Frosted Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-660-45 1 in 1 CARTON 05/01/2012 09/30/2019 1 127 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-660-09 1 in 1 CARTON 05/01/2012 09/30/2019 2 25 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 not final part356 01/29/2012 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-660)