Label: CVS EXTRA WHITENING- sodium fluoride and potassium nitrate paste, dentifrice
- NDC Code(s): 59779-840-02, 59779-840-09
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 5, 2012
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- Active ingredients / Purpose
Potassium nitrate 5%....................................................Antihypersensitivity
Sodium fluoride 0.24% (0.15% w/v fluoride ion)............AnticavityClose
aids in the prevention of dental cavitiesClose
If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.Close
- DOSAGE & ADMINISTRATION
Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.Close
- Other Information
Store in a cool dry place. Keep tube capped when not in use.Close
- Inactive ingredients
cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gumClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
CVS EXTRA WHITENING
fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-840 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.24 g in 100 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) NITRATE ION 5.0 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) HYDRATED SILICA (UNII: Y6O7T4G8P9) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) Product Characteristics Color Score Shape Size Flavor MINT (mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-840-09 1 in 1 CARTON 1 NDC:59779-840-02 170 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/20/2011 Labeler - CVS Pharmacy (062312574) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations Lornamead 126440440 manufacture(59779-840) , pack(59779-840)