Rexall™

Rexall™
SPL v3
SPL
SPL Set ID 1bfba18b-1418-4c39-b666-96fa0674cc70
Route
DENTAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.3 mg)
Inactive Ingredients
Sorbitol Hydrated Silica Water Polyethylene Glycol 1600 Sodium Lauryl Sulfate Glycerin Carboxymethylcellulose Sodium, Unspecified Titanium Dioxide Sodium Pyrophosphate Sodium Benzoate Benzyl Alcohol Saccharin Sodium Sodium Phosphate, Tribasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-12

Description

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

Anticavity toothpaste


Medication Information

Purpose

Anticavity toothpaste

Description

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Use

helps protect against cavities

Section 42229-5

Conforms to airline carry-on regulations

TO ASSEMBLE TOOTHBRUSH:

Insert plug end of toothbrush into handle for use.

Insert brush end of toothbrush into handle for storage.

Visit us at : Rexall.com 

Since 1903 Rexall™ is a Trademark of Rexall Sundown, Inc.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

MADE IN INDIA

Section 50565-1

Keep out of the reach of children under 6 yrs. of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. 

Packaging

Warnings:

Directions

• Adults and children 2 years of age & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.

• Children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing to minimize swallowing

• Children under 2 years: ask a dentist or physician.

Drug Facts

Active Ingredient

Sodium monofluorophosphate 0.76%

(0.13% w/v fluoride ion)

Inactive Ingredients:

Sorbitol, Hydrated Silica, Treated Water (Aqua), Poly Ethylene Glycol 1500 (PEG-32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (CI 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate

Questions Or Comments?

Call toll free 1-866-4-REXALL


Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Conforms to airline carry-on regulations

TO ASSEMBLE TOOTHBRUSH:

Insert plug end of toothbrush into handle for use.

Insert brush end of toothbrush into handle for storage.

Visit us at : Rexall.com 

Since 1903 Rexall™ is a Trademark of Rexall Sundown, Inc.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

MADE IN INDIA

Section 50565-1 (50565-1)

Keep out of the reach of children under 6 yrs. of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. 

Purpose

Anticavity toothpaste

Packaging

Warnings:

Directions

• Adults and children 2 years of age & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.

• Children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing to minimize swallowing

• Children under 2 years: ask a dentist or physician.

Drug Facts

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76%

(0.13% w/v fluoride ion)

Inactive Ingredients: (Inactive ingredients:)

Sorbitol, Hydrated Silica, Treated Water (Aqua), Poly Ethylene Glycol 1500 (PEG-32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (CI 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate

Questions Or Comments? (Questions or comments?)

Call toll free 1-866-4-REXALL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)