COLGATE SENSITIVE ENAMEL PROTECT- sodium fluoride and potassium nitrate paste, 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
enamel protect

Drugs Facts

Active ingredients	Purpose
Potassium nitrate 5%	Antisensitivity
Sodium fluoride 0.24% (0.15% 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, sorbitol, glycerin, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin, xanthan gum, titanium dioxide

Questions or comments?

call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 Made in Mexico
www.colgatesensitive.com

PRINCIPAL DISPLAY PANEL - 170 g Carton

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

Clinically Proven
Sensitivity Relief

NET WT 6.0 OZ (170 g)

MAXIMUM STRENGTH*

Sensitive
enamelprotect

✓: Helps Protect Against Acid Wear
✓: Hardens Enamel

COLGATE SENSITIVE ENAMEL PROTECT
sodium fluoride and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-044
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.4 mg in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM NITRATE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	122.97 mg in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)	16 mg in 1 g
SORBITOL (UNII: 506T60A25R)	363 mg in 1 g
GLYCERIN (UNII: PDC6A3C0OX)	200 mg in 1 g
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)	30 mg in 1 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)	5 mg in 1 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	39.99 mg in 1 g
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)	6.9 mg in 1 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	9 mg in 1 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	2.7 mg in 1 g
XANTHAN GUM (UNII: TTV12P4NEE)	2 mg in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	5 mg in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:65954-044-60	1 in 1 CARTON
1		170 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	11/30/2010

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

Revised: 12/2010

Document Id: 84c881a1-2013-4e2a-bfda-8abf512a0b1c

Set id: eb309cfc-d8df-4612-9c4e-622f0da1a579

Version: 1

Effective Time: 20101203

Mission Hills S.A. de C.V.