Label: CREST SENSITIVITY WHITENING PLUS SCOPE- sodium fluoride and potassium nitrate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 37000-898-06, 37000-898-12, 37000-898-41 - Packager: The Procter & Gamble Manufacturing Company
- 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 March 31, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
- do not swallow
- 12 yrs. & older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
- do not use in children under 12 yrs.
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
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INGREDIENTS AND APPEARANCE
CREST SENSITIVITY WHITENING PLUS SCOPE
sodium fluoride and potassium nitrate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-898 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) BENZOIC ACID (UNII: 8SKN0B0MIM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ALCOHOL (UNII: 3K9958V90M) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color blue Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-898-41 1 in 1 CARTON 01/01/2018 06/18/2019 1 116 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:37000-898-06 1 in 1 CARTON 01/01/2018 2 170 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:37000-898-12 2 in 1 CARTON 01/01/2018 3 170 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 01/01/2018 Labeler - The Procter & Gamble Manufacturing Company (004238200) Establishment Name Address ID/FEI Business Operations Jost Chemical Co. 147882294 api manufacture(37000-898)