Rexall

Rexall
SPL v2
SPL
SPL Set ID 691c9638-75d2-4e53-bec4-2eafacd7216c
Route
DENTAL
Published
Effective Date 2022-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (4.54 mg)
Inactive Ingredients
Glycerin Silicon Dioxide Water Polyethylene Glycol 400 Polyethylene Glycol 1600 Sodium Lauryl Sulfate Sodium Pyrophosphate Sodium Phosphate, Tribasic, Dodecahydrate Titanium Dioxide Cocamidopropyl Betaine Saccharin Sodium Xanthan Gum Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Benzyl Alcohol

Identifiers & Packaging

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

Description

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

Purpose

Anticavity, Antihypersensitivity


Medication Information

Purpose

Anticavity, Antihypersensitivity

Description

Stannous Fluoride 0.454% (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

​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

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.

Packaging

​purpose

Anticavity, Antihypersensitivity

​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

​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.

​drug Facts

​active Ingredient

Stannous Fluoride 0.454%

(0.15% w/v Fluoride ion)

​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


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)

​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

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.

Packaging

​purpose (​Purpose)

Anticavity, Antihypersensitivity

​warnings (​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

​directions (​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.

​drug Facts (​Drug Facts)

​active Ingredient (​Active ingredient)

Stannous Fluoride 0.454%

(0.15% w/v Fluoride ion)

​other Information (​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 (​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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)