CVS ENAMEL GUARD- fluoride paste, dentifrice

CVS by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0..24% (0.15% w/v fluoride ion).........................Anticavity

Uses

• builds increasing protection against painful sensitivty of teeth to cold, heat, acids, sweets or contact
• aids in the prevention of dental cavities

WARNINGS

When using this product, if irritation accurs discontinue use.

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.

Stop use and ask a dentist if

• if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
• pain/sensitivity still persists after 4 weeks of use.

Directions

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

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 toothbrush.

• brush thoroughly for at least one minute twice a day, or as recommended by a dentist or doctor.
• Children under 12 years of age: Consult a dentist or a doctor.

Other Information

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

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS  ENAMEL GUARD
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-128
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 NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g

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

Product Characteristics
Color	white (white to light tan)	Score
Shape		Size
Flavor	MINT (mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-128-89	1 in 1 CARTON	11/30/2012
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 Drug	M022	01/20/2011

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Products (119559733)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Products		119559733	manufacture(51316-128) , pack(51316-128)