Active ingredient Purpose

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

Uses

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

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.

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)

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

Carton R3

SENSITIVE RAPID RELIEF
stannous fluoride paste

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	06/02/2020

Labeler - Rite Aid (014578892)

Registrant - Lornamead (126440440)

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

5820014 Sensitive Rapid Relief

Uses

Directions