Label: CREST PRO-HEALTH GUM AND SENSITIVITY GENTLE CLEANING- stannous fluoride paste, dentifrice
- NDC Code(s): 37000-931-41, 37000-931-85
- Packager: The Procter & Gamble Manufacturing Company
- 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 May 31, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purposes
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Uses
- aids in the prevention of cavities
- helps prevent gingivitis
- helps interfere with the harmful effects of plaque associated with gingivitis
- helps control plaque bacteria that contribute to the development of gingivitis
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
- Warnings
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Directions
- adults and children 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 swallow
- children under 12 yrs.: ask a dentist
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 116 g Tube Carton
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INGREDIENTS AND APPEARANCE
CREST PRO-HEALTH GUM AND SENSITIVITY GENTLE CLEANING
stannous fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-931 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) ZINC CITRATE (UNII: K72I3DEX9B) STANNOUS CHLORIDE (UNII: 1BQV3749L5) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM GLUCONATE (UNII: R6Q3791S76) CARRAGEENAN (UNII: 5C69YCD2YJ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM HYDROXIDE (UNII: 55X04QC32I) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-931-85 1 in 1 CARTON 07/01/2019 1 24 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:37000-931-41 1 in 1 CARTON 07/01/2019 2 116 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 07/01/2019 Labeler - The Procter & Gamble Manufacturing Company (004238200)