Frida Fluoride Bubble Mint Paste, Dentifrice
FDA Label NDC 72705-503

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fridababy, Llc for the product Frida Fluoride Bubble Mint (NDC 72705-503). 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 active ingredient, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, additional labeling information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Sodium fluoride 0.22% (0.13% w/v fluoride ion)

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

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.

Keep Out Of Reach Of Children

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

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after meals 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 swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

sorbitol, water, hydrated silica, xylitol, cellulose gum, disodium EDTA, flavor, mica, PEG-32, phenoxyethanol, potassium sorbate, sodium citrate, sodium lauroyl sarcosinate, stevia leaf extract, titanium dioxide, tocopheryl acetate

Additional Labeling Information

Questions? 1-833-983-3743

Ages 2+; Fluoride strengthens enamel to help prevent cavities; Removes plaque for cleaner, healthier teeth; NET WT 4 OZ / 113 g.

Manufactured for Fridababy LLC, Miami, FL 33137. Made in Malaysia.

Package Label.Principal Display Panel - Carton

Principal display panel / package label image - Carton

Labeling Image Mm1 (Kids Bubble Mint 72705 503 01 Carton)

Labeling Image Mm1 (Kids Bubble Mint 72705 503 01 Carton)

Package Label.Principal Display Panel - Tube

Principal display panel / package label image - Tube

Labeling Image Mm2 (Kids Bubble Mint 72705 503 01 Tube)

Labeling Image Mm2 (Kids Bubble Mint 72705 503 01 Tube)

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