RITE AID PRO DEFENSE WHITENING- stannous fluoride paste, dentifrice

Rite Aid Pro Defense by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Stannous fluoride 0.454% (w/w)

PURPOSE

Purpose

Anticavity / Anti-gingivitis

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

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

• 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.

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

DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL

RITE AID® PHARMACY

oral care

pro defense

daily fluoride anticavity & anti-gingivitis toothpaste

whitening

NET WT 3.4 OZ (96.4 g)

INGREDIENTS AND APPEARANCE

RITE AID PRO DEFENSE  WHITENING
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-6034
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
WATER (UNII: 059QF0KO0R)
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)

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: 11822-6034-9	1 in 1 CARTON	03/03/2019
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	03/03/2019

Labeler - Rite Aid (014578892)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(11822-6034)