ENAMEL HEALTH MULTI-PROTECTION- potassium nitrate and sodium fluoride paste, dentifrice

Enamel Health Multi-Protection by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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, mica, titanium dioxide, D&C yellow no. 10, 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

STRENGTHEN & REPLENISH

• ✓ STRENGTHENS ENAMEL 4X BETTER†
• ✓ HELPS REPLENISH NATURAL CALCIUM

ENAMEL
HEALTH

MULTI-PROTECTION

+ SENSITIVITY RELIEF

NET WT 6.0 OZ (170 g)
COOL MINT gel

INGREDIENTS AND APPEARANCE

ENAMEL HEALTH MULTI-PROTECTION 
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-389
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	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ZINC PHOSPHATE (UNII: 1E2MCT2M62)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-389-69	1 in 1 CARTON	06/12/2015
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-389-85	1 in 1 CARTON	01/06/2017
2		204 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-389-60	1 in 1 CARTON	12/06/2017
3		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	06/12/2015

Labeler - Colgate-Palmolive (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-389)