COLGATE SENSITIVE MAXIMUM STRENGTH MINT CLEAN- sodium fluoride and potassium nitrate paste, dentifrice
Colgate-Palmolive Company

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.

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Colgate® Sensitive Maximum Strength Mint Clean Toothpaste

Drug Facts

Active ingredients	Purpose
Potassium nitrate 5%	Antisensitivity
Sodium fluoride 0.24% (0.14% w/v fluoride ion)	Anticavity

Uses

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
helps protect against cavities

Warnings

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.

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.

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

water, hydrated silica, glycerin, sorbitol, PEG-12, tetrapotassium pyrophosphate, PVM/MA copolymer, flavor, sodium lauryl sulfate, poloxamer 407, sodium hydroxide, sodium saccharin, cellulose gum, xanthan gum, titanium dioxide

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

Sensitive

Maximum Strength†

Mint Clean
paste

NET WT 1.8 OZ (51 g)

Principal Display Panel - 51 g Tube Carton

COLGATE SENSITIVE MAXIMUM STRENGTH MINT CLEAN
sodium fluoride and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35000-968
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	189.046 mg in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:35000-968-99	1 in 1 CARTON	01/05/2014
1		51 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	01/05/2014	01/14/2021

Labeler - Colgate-Palmolive Company (001344381)

Revised: 12/2019

Document Id: 9a90f7b8-e025-4fdd-858a-f97296d05a4a

Set id: e432fcd6-38f5-4182-9641-f3d15e8b445d

Version: 2

Effective Time: 20191218

Colgate-Palmolive Company