Made By Dentists Rebuilding Toothpaste

Made By Dentists Rebuilding Toothpaste
SPL v5
SPL
SPL Set ID d85f52ca-6339-4ec2-a910-61ddca91a21d
Route
DENTAL
Published
Effective Date 2023-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (5 g) Fluoride Ion (0.24 g)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Citric Acid Monohydrate Cocamidopropyl Betaine Hydrated Silica Tribasic Calcium Phosphate Potassium Sorbate Sodium Bicarbonate Saccharin Sodium Sodium Tripolyphosphate Anhydrous Sorbitol Titanium Dioxide Water Xylitol

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:

Sensitive teeth may indicate a serious problem

that may need prompt care by a dentist. See

your dentist if the problem persists or worsens.

Do not use this product longer than 4 weeks

unless recommended by a dentist or doctor.

Indications and Usage

Use: Aids in the prevention of cavities. Helps

Reduce painful sensitivity of teeth to cold,

heat, acids, sweets, or contact.

Dosage and Administration

Directions:

• Adults and children 12 years of age and older:

  Apply at least a 1-inch strip of the product onto a

  soft bristle toothbrush. Brush teeth thoroughly for

  at least 1 minute twice a day, (morning and evening)

  or as recommended by a dentist or doctor.

• Make sure to brush all sensitive areas of the teeth.

• Children under 12 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:

Cellulose Gum, Citric Acid, Cocamidopropyl

Betaine, Flavor, Hydrated Silica, Hydroxyapatite,

Potassium Sorbate, Sodium Bicarbonate, Sodium

Saccharin, Sodium Tripolyphosphate, Sorbitol,

Titanium Dioxide, Water, Xylitol

Section 53413-1

Questions?   +1 (646) 980-6461

Section 55105-1

Purpose

Potassium Nitrate ....  Desensitizer

Sodium Fluoride ....... Anticavity

Section 55106-9

Active ingredient:

Potassium Nitrate 5.0%

Sodium Fluoride 0.24%

Rebuilding Toothpaste Product Labeling

Rebuilding Toothpaste

Made By Dentists ​™

Fresh Mint Flavor

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. Helps

Reduce painful sensitivity of teeth to cold,

heat, acids, sweets, or contact.

Dosage and Administration (34068-7)

Directions:

• Adults and children 12 years of age and older:

  Apply at least a 1-inch strip of the product onto a

  soft bristle toothbrush. Brush teeth thoroughly for

  at least 1 minute twice a day, (morning and evening)

  or as recommended by a dentist or doctor.

• Make sure to brush all sensitive areas of the teeth.

• Children under 12 years of age: Consult a dentist

  or doctor.

Warnings and Precautions (34071-1)

Warnings:

Sensitive teeth may indicate a serious problem

that may need prompt care by a dentist. See

your dentist if the problem persists or worsens.

Do not use this product longer than 4 weeks

unless recommended by a dentist or doctor.

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:

Cellulose Gum, Citric Acid, Cocamidopropyl

Betaine, Flavor, Hydrated Silica, Hydroxyapatite,

Potassium Sorbate, Sodium Bicarbonate, Sodium

Saccharin, Sodium Tripolyphosphate, Sorbitol,

Titanium Dioxide, Water, Xylitol

Section 53413-1 (53413-1)

Questions?   +1 (646) 980-6461

Section 55105-1 (55105-1)

Purpose

Potassium Nitrate ....  Desensitizer

Sodium Fluoride ....... Anticavity

Section 55106-9 (55106-9)

Active ingredient:

Potassium Nitrate 5.0%

Sodium Fluoride 0.24%

Rebuilding Toothpaste Product Labeling

Rebuilding Toothpaste

Made By Dentists ​™

Fresh Mint Flavor

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

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