Label: COLGATE TOTAL SF CLEAN MINT- stannous fluoride paste, dentifrice
- NDC Code(s): 65954-820-25, 65954-820-60
- 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.
Drug Label Information
Updated July 28, 2022
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purposes
- Uses
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Warnings
When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.
Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
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Directions
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adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled 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 years of age: consult a dentist.
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adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist.
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
Colgate®
Anticavity, Antigingivitis and Antisensitivity ToothpasteRecyclable
Tube✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL ✓TARTAR ✓FRESH BREATH
✓WHITENS ✓SENSITIVITY RELIEF ✓DEEP CLEAN ✓ODOR NEUTRALIZATIONFIGHTS BACTERIA ON TEETH, TONGUE, CHEEKS AND GUMS
12
HR
ANTIBACTERIAL
PROTECTION*
STANNOUS FLUORIDETotal
WHOLE MOUTH HEALTHCLEAN MINT
NET WT 6.0 OZ (170 g)
Paste
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INGREDIENTS AND APPEARANCE
COLGATE TOTAL SF CLEAN MINT
stannous fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-820 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) ZINC PHOSPHATE (UNII: 1E2MCT2M62) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 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:65954-820-25 1 in 1 CARTON 07/25/2022 1 24.9 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:65954-820-60 1 in 1 CARTON 07/25/2022 2 170 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 07/25/2022 Labeler - Mission Hills S.A de C.V (812312122) Registrant - Colgate-Palmolive Company (001344381)