CVS PHARMACY PRO DEFENSE- 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 Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Stannous Fluoride (0.454% w/w)

PURPOSE

Purpose

Anticavity/Antigingiviitis

INDICATIONS & USAGE

Uses

• aids in the prevention of dental cavities
• helps control bleeding gums
• helps interfere with harmful effects of plaque associated with gingivitis

WARNINGS

Warnings

When using this product, discontinue use if irritation occurs.

Stop use and ask a dentist if

• gingivitis, bleeding or redness persists for more than 2 weeks
• if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be signs or symptoms of periodontis, a serious form of gum disease.

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 2 years of age and older:

• Brush teeth thoroughly preferably after each meal or at least twice a day and not more than 3 times a day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.

• To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established.

Children under 2 years of age: consult a dentist or doctor

OTHER SAFETY INFORMATION

Other information

• products containing Stannous Fluoride may cause surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent, and may be removed by your dentist.
• This product is specially formulated to help prevent staining.
• Store below 77F (25C)
• Keep tube capped when not in use.

INACTIVE INGREDIENT

Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, cellulose gum, cocamidopropyl betaine, titanium dioxide, sodium lauryl sulfate, flavor, sodium saccharin

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2017 CVS/pharmacy

CVS.com 1-800-SHOP CVS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS PHARMACY  PRO DEFENSE
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-872
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.454 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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: 69842-872-19	1 in 1 CARTON	06/01/2017
1		96.4 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 final	part355	06/01/2017

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(69842-872)