Cvs Pharmacy Pro Defense (Fluoride) Paste, Dentifrice [Cvs Pharmacy] -

CVS PHARMACY PRO DEFENSE (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]
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NDC	69842-872-19
Set ID	445ec57e-dc3c-49a0-8ca9-4806fcdc0303
Category	HUMAN OTC DRUG LABEL
Packager	CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number	PART355

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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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/01/2017

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Inc. (078584069)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead Inc.		080046418	manufacture(69842-872)

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Medic

CVS PHARMACY PRO DEFENSE (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]

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