Label: CREST 3D WHITE WHITENING THERAPY ENAMEL CARE- sodium fluoride paste, dentifrice
- NDC Code(s): 37000-457-41, 37000-457-85
- Packager: Procter & Gamble Manfuacturing 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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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
- do not swallow
- to minimize swallowing use a pea-sized amount in children under 6
- supervise children's brushing until good habits are established
- children under 2 yrs.: ask a dentist
- adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 116 g Carton
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INGREDIENTS AND APPEARANCE
CREST 3D WHITE WHITENING THERAPY ENAMEL CARE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-457 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARRAGEENAN (UNII: 5C69YCD2YJ) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) XANTHAN GUM (UNII: TTV12P4NEE) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERIN (UNII: PDC6A3C0OX) HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) MICA (UNII: V8A1AW0880) Product Characteristics Color white Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-457-41 1 in 1 CARTON 07/12/2017 1 116 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:37000-457-85 1 in 1 CARTON 07/12/2017 2 24 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 07/12/2017 Labeler - Procter & Gamble Manfuacturing Company (004238200)