The following Structured Product Label (SPL) was submitted to the FDA by Level Oral Care, Llc for the product Level Anticavity (NDC 50001-111). 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, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient: Purpose
Sodium monofluorophoshate 0.76 percent Anticaries
Uses:
Aids in the prevention of dental cavities.
Warnings:
Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach children under 6 years of age.
Directions:
Adults and children 2 years of age and older: Apply Level Toothpaste onto a soft bristle toothbrush. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Use a pea-sized amount. Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients: purified water, glycerin, sorbitol, xylitol hydrated silica, calcium carbonate,
tetrasodium pyrophosphate, sodium lauryl sulfate, sodium bicarbonate, sodium saccharin,
cellulose gum, sodium benzoate, flavor
xylitol
Natural Enamel Protection
True Protection with fluoride
Gentle, yet powerful whitening agents
Ultimate freshness formula
Enamel Guard with pH stabilizers
Level
Mint Five
Anticavity Toothpaste
perfect your smile
NET WT 5.0 oz (141.7 g)
Minttoothpaste (Levelone)
Minttoothpastedrugfacts (Levelfive)
Minttoothpaste1oz (Levelfive2)
Level
Mint One
Anticavity Toothpaste
perfect your smile
NET WT 1.0 oz (28.3 g)
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