Active Ingredient
Sodium fluoride 0.22% (0.13% w/v fluoride ion)
Frida Fluoride Watermelon Paste, Dentifrice
FDA Label NDC 72705-501
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 Watermelon (NDC 72705-501). 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.
Label Section Quick Index
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, butylene glycol, cellulose gum, disodium EDTA, flavor, mica, PEG-32, phenoxyethanol, potassium sorbate, sodium citrate, sodium lauroyl sarcosinate, stevia leaf extract, watermelon (citrullus lanatus) fruit 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 Watermelon 72705 501 01 Carton)
Package Label.Principal Display Panel - Tube
Principal display panel / package label image - Tube
Labeling Image Mm2 (Kids Watermelon 72705 501 01 Tube)
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