PRO DEFENSE MINT- stannous fluoride paste, dentifrice

Pro Defense by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

PURPOSE

Purpose

Anticavity / Antigingivitis

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, if irritation occurs discontinue use.

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 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 accidentally 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 day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing

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

STORAGE AND HANDLING

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 your dentist.
• This product is specifically formulated to help prevent staining
• store below 77°F (25°C)
• 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

Contains stannous fluoride, clinically proven to help control bleeding gums.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

©2018 CVS/pharmacy

CVS.com

1-800-SHOP CVS

PRINCIPAL DISPLAY PANEL

CVS Health™

Pro Defense Clean Mint

DAILY FLUORIDE ANTI-CAVITY & ANTI-GINGIVITIS TOOTHPASTE

• Helps prevent bleeding gums
• For healthy gums and strong teeth

NET WT 3.4 OZ (96.4 g)

INGREDIENTS AND APPEARANCE

PRO DEFENSE  MINT
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-254
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
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-254-19	1 in 1 CARTON	02/08/2019
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 not final	part356	02/08/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(69842-254)