REXALL SENSITIVE FRESHMINT- potassium nitrate, sodium 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.

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Rexall™ SENSITIVE TOOTHPASTE WITH FLUORIDE - FRESH MINT

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, Flavor, Glycerin, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Benzyl Alcohol, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, D&C Yellow #10, FD&C Blue #1

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 & clean

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

Old East-819

REXALL SENSITIVE FRESHMINT 
potassium nitrate, sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-819
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-819-011 in 1 BOX03/21/2022
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/21/2022
Labeler - Old East Main CO. (068331990)
Registrant - Ashtel Studios Inc. (148689180)

Revised: 3/2022
Document Id: 64e9642d-ce32-4ac6-8b29-36c9b7ef896d
Set id: 7e715bb9-666e-4de4-ba70-1c84f5243443
Version: 1
Effective Time: 20220324
 
Old East Main CO.