supermouth super chocolate prescription toothpaste

supermouth super chocolate prescription toothpaste
SPL v3
SPL
SPL Set ID bbaccbe4-82ac-4c51-8fc4-a96bf86dfef2
Route
dental
Published
Effective Date 2023-10-15
Document Type 34391-3 Human Prescription Drug Label

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.1 g)
Inactive Ingredients
glycerin water hydrated silica tribasic calcium phosphate menaquinone 7 cholecalciferol xylitol inulin sodium gluconate dimethyl sulfone xanthan gum quillaja saponaria whole benzoic acid sodium ascorbate stevia leaf cranberry seed oil

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2023-10-13

Description

ACTIVE INGREDIENT Sodium Fluoride 1.1% (5000 ppm)


Medication Information

Dosage and Administration

DIRECTIONS: Use as directed by a dentist or physician.

Description

ACTIVE INGREDIENT Sodium Fluoride 1.1% (5000 ppm)

Section 42229-5

ACTIVE INGREDIENT

Sodium Fluoride 1.1% (5000 ppm)

Section 43685-7

WARNINGS: Do not swallow. Do not use in children under 6 years of age unless recommended by a dentist or physician. 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.

See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Section 51727-6

USE: This medication is used as part of a professional program for the prevention and control of dental caries. Use as directed by your health professional.

Principal Display Panel Supermouth Super Chocolate Prescription Toothpaste

Supermouth Pro

1.1% sodium fluoride

5000 ppm

Anticavity Toothpaste

Rx Only

super chocolate

content: 1 tube 3.4oz (96g)

Dist by: SuperMouth®

9737 Aero Drive

San Diego, CA

844-MOUTHCARE

Made In The USA with

Domestic & global materials

res


Structured Label Content

Dosage and Administration (34068-7)

DIRECTIONS: Use as directed by a dentist or physician.

Section 42229-5 (42229-5)

ACTIVE INGREDIENT

Sodium Fluoride 1.1% (5000 ppm)

Section 43685-7 (43685-7)

WARNINGS: Do not swallow. Do not use in children under 6 years of age unless recommended by a dentist or physician. 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.

See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Section 51727-6 (51727-6)

USE: This medication is used as part of a professional program for the prevention and control of dental caries. Use as directed by your health professional.

Principal Display Panel Supermouth Super Chocolate Prescription Toothpaste (PRINCIPAL DISPLAY PANEL - SuperMouth Super Chocolate Prescription Toothpaste)

Supermouth Pro

1.1% sodium fluoride

5000 ppm

Anticavity Toothpaste

Rx Only

super chocolate

content: 1 tube 3.4oz (96g)

Dist by: SuperMouth®

9737 Aero Drive

San Diego, CA

844-MOUTHCARE

Made In The USA with

Domestic & global materials

res


Advanced Ingredient Data


Raw Label Data

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