SENSITIVITY AND GUM- stannous fluoride paste, dentifrice

Sensitivity and Gum by

Drug Labeling and Warnings

Sensitivity and Gum by is a Otc medication manufactured, distributed, or labeled by DG Health (Rexall), Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion)

Purpose

Anticavity, Antigingivitis, Antihypersensitivity

Uses

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

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.

Keep out of reach of children

If more than is 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 unto 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.

Other information

products containing stannous fluoride may produce surface staining of the teeth. Adequate 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 help prevent staining. * store below 30*C (86*F)

Inactive ingredients

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

SENSITIVITY AND GUM 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-569
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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: 55910-569-19	1 in 1 CARTON	01/11/2024
1		65.2 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	01/11/2024

Labeler - DG Health (Rexall) (068331990)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(55910-569) , pack(55910-569)