RITE AID SENSITIVE RAPID PROTECTION- stannous fluoride paste, dentifrice

Rite Aid Sensitive by

Drug Labeling and Warnings

Rite Aid Sensitive by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Lornamead, 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 / Antihypersensitivity

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

When using this product, if irritation occurs discontinue use.

Stop use and ask a dentist if:

• the problem persists or 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

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.

DOSAGE & ADMINISTRATION

Directions

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 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.
• Do not swallow
• Children under 12 years of age: consult a dentist or doctor.

STORAGE AND HANDLING

Other information

products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing 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 30°C (86°F)

INACTIVE INGREDIENT

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

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DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL

RITE AID® PHARMACY

oral care

sensitive toothpaste

rapid protection

for sensitive teeth and cavity protection

extra fresh

NET WT 3.4 OZ (96.4 g)

INGREDIENTS AND APPEARANCE

RITE AID SENSITIVE  RAPID PROTECTION
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-6031
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		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-6031-9	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 (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(11822-6031)