Label: COLGATE TOTAL GUM PROTECTION- stannous fluoride paste, dentifrice
- NDC Code(s): 35000-572-32, 35000-572-48, 35000-572-96
- Packager: Colgate-Palmolive 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 January 19, 2023
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 - Two 136 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
2
VALUE
PACKTotal
WHOLE MOUTH HEALTH12
HR
ANTIBACTERIAL
PROTECTION*STANNOUS FLUORIDE
GUM
PROTECTION
PasteTWO 4.8 OZ (136 g) TUBES
TOTAL NET WT 9.6 OZ (272 g) -
INGREDIENTS AND APPEARANCE
COLGATE TOTAL GUM PROTECTION
stannous fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-572 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) ZINC PHOSPHATE (UNII: 1E2MCT2M62) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SACCHARIN SODIUM (UNII: SB8ZUX40TY) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:35000-572-48 1 in 1 CARTON 12/11/2020 12/30/2024 1 136 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:35000-572-96 2 in 1 CARTON 12/21/2020 12/30/2024 2 136 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:35000-572-32 1 in 1 CARTON 01/21/2021 12/30/2024 3 93 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 12/11/2020 12/30/2024 Labeler - Colgate-Palmolive Company (001344381)