COLGATE ENAMEL HEALTH SENSITIVITY RELIEF- potassium nitrate and sodium fluoride gel, dentifrice

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient 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.

Active ingredient	Purpose
Potassium nitrate 5%	Antisensitivity
Sodium fluoride 0.24% (0.15% w/v fluoride ion)	Anticavity

Directions

adults and children 2 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, hydrated silica, glycerin, PEG-12, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, microcrystalline cellulose, zinc phosphate, cellulose gum, cocamidopropyl betaine, benzyl alcohol, sodium saccharin, xanthan gum, mica, titanium dioxide, FD&C blue no. 1
Questions?

1-800-468-6502
SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
Colgate®
Anticavity Toothpaste for Sensitive Teeth

ENAMEL
HEALTH

SENSITIVITY RELIEF

STRENGTHEN & REPLENISH
- ✓ STRENGTHENS ENAMEL 4X BETTER†
- ✓ HELPS REPLENISH NATURAL CALCIUM
NET WT 6.0 OZ (170 g)
FRESH MINT gel

INGREDIENTS AND APPEARANCE

COLGATE ENAMEL HEALTH SENSITIVITY RELIEF
potassium nitrate and sodium fluoride gel, dentifrice

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
ZINC PHOSPHATE (UNII: 1E2MCT2M62)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 35000-206-20	1 in 1 CARTON	06/30/2014
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-206-69	1 in 1 CARTON	06/30/2014
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-206-26	1 in 1 CARTON	06/30/2014
3		155 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-206-60	1 in 1 CARTON	11/30/2017
4		170 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	06/30/2014

Labeler - Colgate-Palmolive (001344381)

Colgate Enamel Health Sensitivity Relief by