CVS PHARMACY ENAMEL GUARD- fluoride paste, dentifrice

CVS Pharmacy by

Drug Labeling and Warnings

CVS Pharmacy by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Potassium Nitrate 5%......................................................................Antihypersensitivity

Sodium Fluoride 0.15% w/v fluoride ion...........................................Anticavity

Uses

aids in the prevention of dental caviites

aids in reducing sensitivity

WARNINGS

If pain/sensitivity persists after 4 weeks of use, please visit your dentist.

Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. Children under 12 years of age: consult a dentist or doctor

Directions

Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch. Brush teeth thorughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidpropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

CVS PHARMACY  ENAMEL GUARD
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-815
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g
POTASSIUM NITRITE (UNII: 794654G42L) (NITRITE ION - UNII:J39976L608)	POTASSIUM NITRITE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-815-49	1 in 1 CARTON	01/07/2013
1	NDC: 59779-815-42	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	10/01/2012

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	manufacture(59779-815) , pack(59779-815)