Made By Dentists Whitening Toothpaste

Made By Dentists Whitening Toothpaste
SPL v3
SPL
SPL Set ID 374fed0e-ae5d-4062-8d55-696498b60714
Route
DENTAL
Published
Effective Date 2023-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g)
Inactive Ingredients
Sorbitol Water Hydrated Silica Xylitol Sodium Tripolyphosphate Anhydrous Cocamidopropyl Betaine Carboxymethylcellulose Sodium, Unspecified Titanium Dioxide Potassium Sorbate Saccharin Sodium Citric Acid Monohydrate Hydrogen Peroxide Sodium Bicarbonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-01-24 Until 2026-06-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings:

Indications and Usage

Use: Aids in the prevention of cavities.

Dosage and Administration

Directions:

• Adults and children 2 years of age and older:

  Brush teeth thoroughly, preferably after each

  meal or at least twice a day, or as directed

  by a dentist or doctor.

• Instruct children under 6 years of age in good

  Brushing and rinsing habits (to minimize swall-

  owing), and only use a pea size amount

• Supervise children as necessary until capable

  of using without supervision.

• Children under 2 years of age: Consult a

  dentist or doctor.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age.If

more than used for brushing is accidentally swallowed, get

medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients:

Sorbitol, Water, Hydrated Silica, Xylitol, Sodium

Tripolyphosphate, Flavor, Cocamidopropyl Betaine,

Cellulose Gum, Titanium Dioxide, Potassium

Sorbate, Sodium Saccharin, Citric Acid, Hydrogen

Peroxide, Sodium Bicarbonate

Section 53413-1

Questions?   +1 (646) 980-6461

Section 55105-1

Purpose   Anticavity

Section 55106-9

Active ingredient:

Sodium Fluoride 0.24%

Whitening Toothpaste Product Labeling

Whitening Toothpaste

Made By Dentists ​™

NET WT 4.2 Oz / 120g

MADE IN THE USA

@Copyright: 2022 Made By Dentists

439 S. Cedros Avenue, Suite 402.

Solana Beach, CA, 92075

Carton

Tube

res


Structured Label Content

Indications and Usage (34067-9)

Use: Aids in the prevention of cavities.

Dosage and Administration (34068-7)

Directions:

• Adults and children 2 years of age and older:

  Brush teeth thoroughly, preferably after each

  meal or at least twice a day, or as directed

  by a dentist or doctor.

• Instruct children under 6 years of age in good

  Brushing and rinsing habits (to minimize swall-

  owing), and only use a pea size amount

• Supervise children as necessary until capable

  of using without supervision.

• Children under 2 years of age: Consult a

  dentist or doctor.

Warnings and Precautions (34071-1)

Warnings:

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.If

more than used for brushing is accidentally swallowed, get

medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients:

Sorbitol, Water, Hydrated Silica, Xylitol, Sodium

Tripolyphosphate, Flavor, Cocamidopropyl Betaine,

Cellulose Gum, Titanium Dioxide, Potassium

Sorbate, Sodium Saccharin, Citric Acid, Hydrogen

Peroxide, Sodium Bicarbonate

Section 53413-1 (53413-1)

Questions?   +1 (646) 980-6461

Section 55105-1 (55105-1)

Purpose   Anticavity

Section 55106-9 (55106-9)

Active ingredient:

Sodium Fluoride 0.24%

Whitening Toothpaste Product Labeling

Whitening Toothpaste

Made By Dentists ​™

NET WT 4.2 Oz / 120g

MADE IN THE USA

@Copyright: 2022 Made By Dentists

439 S. Cedros Avenue, Suite 402.

Solana Beach, CA, 92075

Carton

Tube

res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)