Otc - Active Ingredient
Active Ingredient: Sodium Fluoride (0.243%)
Upc 801803 00211 Megafresh Gel Fluoride Tooth
FDA Label NDC 54157-109
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Amenities, Inc. for the product Upc 801803 00211 Megafresh Gel Fluoride Tooth (NDC 54157-109). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Anticavity
Indications & Usage
Uses: Aids in the prevention of dental cavities
Warnings
If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under six years of age
Dosage & Administration
Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.
Inactive Ingredient
Sorbitol, Hydrated Silica, Glycerin, Purified Water, Polyethylene Glycol, Sodium Lauryl Sulfate, Carboxymethylcellulose Sodium, Flavor, Xanthan Gum, Saccharin Sodium, Methylisothiazolinone
Package Label.Principal Display Panel
Label (Tp 06c)
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