REXALL SENSITIVE EXTRA WHITENING- potassium nitrate, sodium fluoride paste, dentifrice

Rexall Sensitive Extra Whitening by

Drug Labeling and Warnings

Rexall Sensitive Extra Whitening by is a Otc medication manufactured, distributed, or labeled by Old East Main CO., Ashtel Studios Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Potassium Nitrate (5%)
Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity
Anticavity

Uses

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

Warnings

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 under 12 years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years & older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush  brush teeth thoroughly for at least two minutes, preferably after each meal or at least twice a day (morning and evening) as recommended by a dentist or physician. 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

Store at room temperature 68-77°F (20-25°C)

Inactive ingredients

Sorbitol, Hydrated Silica, Treated water, PEG-32, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Benzyl Alcohol, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, Sodium Hydroxide

SPL UNCLASSIFIED SECTION

MAXIMUM STRENGTH

TOOTHPASTE WITH FLUORIDE

For sensitive teeth and cavity protection

Brushing twice a day builds a protective coating against painful sensitivity.

Contains potassium nitrate, clinically proven to reduce painful sensitivity
Fluoride for cavity protection
Great taste keeps mouth feeling fresh & clear

Since 1903 Rexall™ is a trademark of Rexall Sundown, Inc.

100% satisfaction Guaranteed!
(888) 309-9030

DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE,
GOODLETTSVILLE, TN 37072

MADE IN INDIA

Packaging

INGREDIENTS AND APPEARANCE

REXALL SENSITIVE EXTRA WHITENING 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-817
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-817-01	1 in 1 BOX	03/21/2022
1		113 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	03/21/2022

Labeler - Old East Main CO. (068331990)

Registrant - Ashtel Studios Inc. (148689180)