Rexall

Rexall
SPL v2
SPL
SPL Set ID 7e715bb9-666e-4de4-ba70-1c84f5243443
Route
DENTAL
Published
Effective Date 2022-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (5 g) Fluoride Ion (0.24 g)
Inactive Ingredients
Sorbitol Hydrated Silica Water Polyethylene Glycol 1600 Sodium Lauryl Sulfate Glycerin Carboxymethylcellulose Sodium, Unspecified Sodium Pyrophosphate Titanium Dioxide Benzyl Alcohol Sodium Benzoate Sodium Phosphate, Tribasic, Anhydrous Saccharin Sodium D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-21

Description

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

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity

Anticavity

Description

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

Uses

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

Section 42229-5

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

Section 50565-1

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.

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

Packaging

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.

Drug Facts

Other Information

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

Active Ingredients

Potassium Nitrate (5%)

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

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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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.

Purpose

Antihypersensitivity

Anticavity

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

Packaging

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.

Drug Facts

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Potassium Nitrate (5%)

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

Inactive Ingredients (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)