Label: COLGATE ULTRA RELIEF- sodium fluoride and potassium nitrate paste, dentifrice
- NDC Code(s): 35000-992-21
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
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 October 19, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
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
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE ULTRA RELIEF
sodium fluoride and potassium nitrate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-992 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) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 189.046 mg in 1 g GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM HYDROXIDE (UNII: 55X04QC32I) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-992-21 1 in 1 CARTON 10/16/2020 1 60 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 10/16/2020 Labeler - Colgate-Palmolive Company (001344381)