Super Strawberry Prescription
FDA Label NDC 83729-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Supermouth, Llc. for the product Super Strawberry Prescription (NDC 83729-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, inactive ingredient, warnings and precautions, dosage & administration, principal display panel - supermouth super strawberry prescription toothpaste, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

ACTIVE INGREDIENT
Sodium Fluoride 1.1% (5000 ppm)

PURPOSE
Sodium Fluoride …. Anticavity

Inactive Ingredient

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.

INACTIVE INGREDIENTS

Glycerin, Water, Hydrated Silica, *Hydroxamin® (Nano-Hydroxyapatite, Menquinone-y (Vit K2), Cholecalciferol (Vit D3)), Xylitol, Inulin, Sodium Gluconate, Methylsulfonylmethane, Xanthan Gum, Quillaja Saponaria Extract, Natural Flavor, Natural Benzoic Acid, Sodium Ascorbate (Vit C), Stevia Leaf Extract, Cranberry Seed Oil.
*Patent-Pending Formulation

Warnings And Precautions

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.

Dosage & Administration

DIRECTIONS: Use as directed by a dentist or physician.

Principal Display Panel - Supermouth Super Strawberry Prescription Toothpaste

Supermouth Pro

1.1% sodium fluoride

5000 ppm

Anticavity Toothpaste

Rx Only

super strawberry

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

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