REXALL RESTORE AND DEFEND SENSITIVE WHITENING- stannous fluoride paste, dentifrice

Rexall Restore and Defend Sensitive Whitening by

Drug Labeling and Warnings

Rexall Restore and Defend Sensitive 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 ingredient

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

​Purpose

Anticavity, Antihypersensitivity

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

​Adult 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 one minute, twice a day (morning and evening) and not more than 3 times a day or 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

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

​Inactive ingredients

glycerin, hydrated silica, treated water, PEG-8, PEG-32, sodium lauryl sulphate, tetrasodium pyrophosphate, flavor, trisodium phosphate, titanium dioxide, cocamidopropyl betaine, sodium saccharin, xanthan gum, polyacrylic acid, benzyl alcohol

SPL UNCLASSIFIED SECTION

​Since 1903​

TOOTHPASTE WITH FLUORIDE

For sensitive teeth and cavity protection
Great for everyday use

​Brushing twice a day with Rexall​™​ Restore & Defend Sensitive Toothpaste helps repair sensitive teeth and protect against painful sensitivity.

Provides daily relief & protection for sensitive teeth*
Contains fluoride for cavity protection
Removes stains for whiter teeth
Freshens breath

​100% Satisfaction Guaranteed!
(888) 309-9030

*With brushing twice daily

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

PRODUCT OF INDIA

Packaging

INGREDIENTS AND APPEARANCE

REXALL RESTORE AND DEFEND SENSITIVE WHITENING 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-820
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	4.54 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-820-01	1 in 1 BOX	03/21/2022
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 final	part355	03/21/2022

Labeler - Old East Main CO. (068331990)

Registrant - Ashtel Studios Inc. (148689180)