Brush Buddies® 

Brush Buddies® 
SPL v1
SPL
SPL Set ID f70d378b-d4d6-454c-90a9-794459960c8c
Route
DENTAL
Published
Effective Date 2025-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.243 g)
Inactive Ingredients
Sorbitol Silicon Dioxide Water Polyethylene Glycol 1600 Xylitol Gelidiella Acerosa D&c Red No. 30 Phthalocyanine Blue Ferrosoferric Oxide Ferric Oxide Yellow Chromic Oxide Sodium Alginate Glycerin Phenoxyethanol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Benzyl Alcohol Titanium Dioxide Sodium Benzoate Saccharin Sodium Sodium Phosphate, Tribasic, Anhydrous Fd&c Yellow No. 6 Carmoisine Fd&c Yellow No. 5 Fd&c Blue No. 1 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-15

Description

Sodium Fluoride 0.243% (Fluoride ion Content 1100 ppm)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.243% (Fluoride ion Content 1100 ppm)

Uses 

• helps protect teeth and roots against cavities.

Section 42229-5

HELPS PREVENT CAVITIES

DESIGNED IN U.S.A.

MADE IN INDIA

WWW.BRUSHBUDDIES.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE



DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CALIFORNIA 91761

Brush 2 Minutes

2 Times Daily

Section 50565-1

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Warnings

Packaging

Directions

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

Do not swallow.

Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.

Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient

Sodium Fluoride 0.243%

(Fluoride ion Content 1100 ppm)

Inactive Ingredients

Sorbitol, Silica, Aqua (Water), PEG-32, Xylitol, Agar Agar, CI 73360, CI 74160, CI 77499, CI 77492, CI 77288, Sodium Alginate, Glycerin, Phenoxyethanol, Deionized Water, Agar Agar, CI 73360, CI 74160, CI 77499, CI 77492, CI 77288, Sodium Alginate, Glycerin, Phenoxyethanol, Deionized Water, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Benzyl Alcohol, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tri Sodium Ortho Phosphate, CI 15985 + CI 14720 + CI 19140 + CI 42090 + CI 42053

Questions Or Comments?

Call toll free 1-877-274-8358


Structured Label Content

Uses 

• helps protect teeth and roots against cavities.

Section 42229-5 (42229-5)

HELPS PREVENT CAVITIES

DESIGNED IN U.S.A.

MADE IN INDIA

WWW.BRUSHBUDDIES.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE



DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CALIFORNIA 91761

Brush 2 Minutes

2 Times Daily

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Purpose

Anticavity

Warnings

Packaging

Directions

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

Do not swallow.

Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.

Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient (Active ingredient)

Sodium Fluoride 0.243%

(Fluoride ion Content 1100 ppm)

Inactive Ingredients (Inactive ingredients)

Sorbitol, Silica, Aqua (Water), PEG-32, Xylitol, Agar Agar, CI 73360, CI 74160, CI 77499, CI 77492, CI 77288, Sodium Alginate, Glycerin, Phenoxyethanol, Deionized Water, Agar Agar, CI 73360, CI 74160, CI 77499, CI 77492, CI 77288, Sodium Alginate, Glycerin, Phenoxyethanol, Deionized Water, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Benzyl Alcohol, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tri Sodium Ortho Phosphate, CI 15985 + CI 14720 + CI 19140 + CI 42090 + CI 42053

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358


Advanced Ingredient Data


Raw Label Data

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