SENSITIVE RAPID RELIEF- stannous fluoride paste

Sensitive Rapid Relief by

Drug Labeling and Warnings

Sensitive Rapid Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion) . . . Anticavity/Antihypersensitivity

PURPOSE

Uses

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

WARNINGS

When using this product, if irritation occurs discontinue use.

Stop use and ask a doctor 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.

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 physician. Make sure to brush all sensitive areas of the teeth. * Do not swallow * Children under 12 years of age: consult a dentist or doctor.

OTHER SAFETY 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 by your dentist. * This product is specifically formulated to help prevent staining. * store below 30*C (86*F)

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENSITIVE RAPID RELIEF 
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0014
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

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

Product Characteristics
Color	white (White to off white)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0014-9	1 in 1 CARTON	06/02/2020
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 Drug	M021	06/02/2020

Labeler - Rite Aid (014578892)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(11822-0014)