COLGATE ENAMEL HEALTH MINERAL REPAIR- potassium nitrate and sodium fluoride paste, dentifrice

Colgate Enamel Health Mineral Repair by

Drug Labeling and Warnings

Colgate Enamel Health Mineral Repair by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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, hydrated silica, glycerin, PEG-12, tetrasodium pyrophosphate, flavor, sodium lauryl sulfate, microcrystalline cellulose, zinc phosphate, cellulose gum, sodium saccharin, cocamidopropyl betaine, xanthan gum, tricalcium phosphate, mica, titanium dioxide, FD&C blue no. 1

Questions?

1-800-468-6502
www.colgate.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

Colgate®

Anticavity & Antisensitivity Toothpaste

ENAMEL
HEALTH™

MINERAL
REPAIR

HELPS REPAIR
WEAKENED ENAMEL
WITH VITAL MINERALS

• ENAMEL EROSION
• SENSITIVITY
• WHITENS
• CAVITIES
• FRESHENS

MINT BURST
gel

NET WT 4.0 OZ (113 g)

INGREDIENTS AND APPEARANCE

COLGATE ENAMEL HEALTH MINERAL REPAIR 
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-209
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)
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-209-69	1 in 1 CARTON	10/12/2015
1		113 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	10/12/2015

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-209)