REXALL RESTORE AND DEFEND SENSITIVE WHITENING- stannous fluoride paste, dentifrice 
Old East Main CO.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Rexall​™ ​SENSITIVE TOOTHPASTE WITH FLUORIDE - WHITENING

​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

​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

IMAGE

REXALL RESTORE AND DEFEND SENSITIVE WHITENING 
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-820
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION4.54 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-820-011 in 1 BOX03/21/2022
196.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/21/2022
Labeler - Old East Main CO. (068331990)
Registrant - Ashtel Studios Inc. (148689180)

Revised: 3/2022
Document Id: b12258a6-8d9e-4d88-ab64-9edf6eabe4d6
Set id: 691c9638-75d2-4e53-bec4-2eafacd7216c
Version: 1
Effective Time: 20220323
 
Old East Main CO.