Label: COLGATE- sodium fluoride and potassium nitrate paste, dentifrice
- NDC Code(s): 65954-044-60
- Packager: Mission Hills S.A. de C.V.
- 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.
Updated December 3, 2010
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
adults and children 12 years of age and 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 or physician. Make sure to brush all sensitive areas of the teeth. children under 12 years consult a dentist or physician
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 170 g Carton
INGREDIENTS AND APPEARANCE
COLGATE SENSITIVE ENAMEL PROTECT
sodium fluoride and potassium nitrate paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-044 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg in 1 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM NITRATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 122.97 mg in 1 g HYDRATED SILICA (UNII: Y6O7T4G8P9) 16 mg in 1 g SORBITOL (UNII: 506T60A25R) 363 mg in 1 g GLYCERIN (UNII: PDC6A3C0OX) 200 mg in 1 g POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) 30 mg in 1 g SODIUM PYROPHOSPHATE (UNII: O352864B8Z) 5 mg in 1 g SODIUM LAURYL SULFATE (UNII: 368GB5141J) 39.99 mg in 1 g CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 6.9 mg in 1 g SODIUM HYDROXIDE (UNII: 55X04QC32I) 9 mg in 1 g SACCHARIN SODIUM (UNII: SB8ZUX40TY) 2.7 mg in 1 g XANTHAN GUM (UNII: TTV12P4NEE) 2 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 5 mg in 1 g Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65954-044-60 1 in 1 CARTON 1 170 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 11/30/2010 Labeler - Mission Hills S.A. de C.V. (812312122)