Colgate® Sensitive Lasting Fresh Mint Burst Gel Toothpaste

Colgate Sensitive Lasting Fresh Mint Burst by

Drug Labeling and Warnings

Colgate Sensitive Lasting Fresh Mint Burst by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE SENSITIVE LASTING FRESH MINT BURST- potassium nitrate and sodium fluoride gel, dentifrice 
Mission Hills S.A de C.V

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 Lasting Fresh Mint Burst Gel 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, PVM/MA copolymer, sodium lauryl sulfate, flavor, poloxamer 407, trisodium phosphate, sodium hydroxide, cellulose gum, sodium saccharin, xanthan gum, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

MAXIMUM STRENGTH*

Colgate®
Toothpaste for Sensitive Teeth
and Cavity Protection

Sensitive

Relieves & Freshens
✓Clinically Proven Sensitivity Relief ✓Long-Lasting Freshness

Lasting Fresh™

NET WT 6.0 OZ (170 g)

Mint Burst
gel

COLGATE SENSITIVE LASTING FRESH MINT BURST 
potassium nitrate and sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-401
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	202.62 mg  in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PHOSPHATE ION (UNII: NK08V8K8HR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-401-60	1 in 1 CARTON	03/04/2017
1		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 NOT FINAL	part356	03/04/2017

Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019

Document Id: 1053aacc-c5b7-4bc8-829b-848d36f9b830

34390-5

Set id: 130d7ab7-f28c-43ee-ae59-c4c1cbab28f4

Version: 2

Effective Time: 20190418