Brush Buddies®

Brush Buddies®
SPL v3
SPL
SPL Set ID 636bf51d-9750-4305-ab4a-3483c9f0169b
Route
DENTAL
Published
Effective Date 2025-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Calcium Carbonate Water Sorbitol Silicon Dioxide Sodium Lauryl Sulfate Benzyl Alcohol Polyethylene Glycol 400 Carboxymethylcellulose Sodium, Unspecified Xanthan Gum Saccharin Sodium Sodium Benzoate Titanium Dioxide Sodium Pyrophosphate Sodium Bicarbonate Sodium Silicate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-15

Description

Sodium Monofluorophosphate (0.76%) (Total fluoride content - 1000 ppm approx.)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Monofluorophosphate (0.76%) (Total fluoride content - 1000 ppm approx.)

Use

Regular brushing with fluoride toothpaste helps protect teeth against cavities.

Section 42229-5

FIGHTS TARTAR AND HELPS WHITEN TEETH*

WITH BAKING SODA

COOL MINT

√ CAVITIES √ TARTAR

√ PLAQUE √ BREATH

√ ENAMEL √ WHITENS

*HELPS WHITEN TEETH WITH REGULAR BRUSHING TWICE A DAY

DESIGNED IN U.S.A. • MADE IN INDIA

WWW.BRUSHBUDDIES.COM

QUESTIONS OR COMMENTS?

1-877-274-8358 TOLL FREE IN USA

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CALIFORNIA 91761

Section 50565-1

Keep out of reach of children under 6 years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Packaging

Directions

 adults and children 2 years & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist  do not swallow • to minimize swallowing, use a pea-sized amount in children under 6 • Supervise children's brushing until good habits are established • Children under 2 years of age: Consult a dentist or doctor. Do not swallow.

Drug Facts

Active Ingredient

Sodium Monofluorophosphate (0.76%)

(Total fluoride content - 1000 ppm approx.)

Inactive Ingredients

Calcium Carbonate, Water(Aqua), Sorbitol, Precipitated Silica, Sodium Lauryl Sulfate, Benzyl Alcohol, Polyethylene Glycol 400, Sodium Carboxymethyl Cellulose, Xanthan Gum, Sodium Saccharin, Sodium Benzoate, Titanium Dioxide, Tetra Sodium Pyrophosphate, Sodium Bicarbonate, Sodium Silicate, CI 42090, Flavor


Structured Label Content

Use

Regular brushing with fluoride toothpaste helps protect teeth against cavities.

Section 42229-5 (42229-5)

FIGHTS TARTAR AND HELPS WHITEN TEETH*

WITH BAKING SODA

COOL MINT

√ CAVITIES √ TARTAR

√ PLAQUE √ BREATH

√ ENAMEL √ WHITENS

*HELPS WHITEN TEETH WITH REGULAR BRUSHING TWICE A DAY

DESIGNED IN U.S.A. • MADE IN INDIA

WWW.BRUSHBUDDIES.COM

QUESTIONS OR COMMENTS?

1-877-274-8358 TOLL FREE IN USA

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CALIFORNIA 91761

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Purpose

Anticavity

Packaging

Directions

 adults and children 2 years & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist  do not swallow • to minimize swallowing, use a pea-sized amount in children under 6 • Supervise children's brushing until good habits are established • Children under 2 years of age: Consult a dentist or doctor. Do not swallow.

Drug Facts

Active Ingredient (Active ingredient)

Sodium Monofluorophosphate (0.76%)

(Total fluoride content - 1000 ppm approx.)

Inactive Ingredients (Inactive ingredients)

Calcium Carbonate, Water(Aqua), Sorbitol, Precipitated Silica, Sodium Lauryl Sulfate, Benzyl Alcohol, Polyethylene Glycol 400, Sodium Carboxymethyl Cellulose, Xanthan Gum, Sodium Saccharin, Sodium Benzoate, Titanium Dioxide, Tetra Sodium Pyrophosphate, Sodium Bicarbonate, Sodium Silicate, CI 42090, Flavor


Advanced Ingredient Data


Raw Label Data

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