RITE AID SENSITIVITY AND GUM- stannous fluoride paste, dentifrice

Rite Aid Sensitivity and Gum by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Stannous Fluoride 0.454% w/w (0.15% w/v fluoride ion) ...... Acticavity, Antigingivitis, Anithypersensitivity

DOSAGE & ADMINISTRATION

Aids in the prevention of dental cavities. Helps interfere with the harmful effects of plaque associated with gingivitis. Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

INDICATIONS & USAGE

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 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: consult a dentist or doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a poision control center right away.

PURPOSE

Products containing stannous fluoride may produce surface staining of the teeth. Adquate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. This product is specifically formulated to prevent staining. Store below 30C or 86F.

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. Gingivitis, bleeding, or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

INACTIVE INGREDIENT

glycerin, water, hydrated silica, petasodium tryiphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamiodpropyl betaine, sodium saccharin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID SENSITIVITY AND GUM 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-5060
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
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)

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: 11822-5060-9	1 in 1 BOX	11/11/2022
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	11/11/2022	01/01/2027

Labeler - Rite Aid (014578892)

Registrant - Lornamead Products (119559733)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Products		119559733	manufacture(11822-5060) , pack(11822-5060)