Otc - Active Ingredient
DRUG FACTS
Active Ingredient Purpose
Sodium Monofluorophosphate 0.76%....Anticaries
Level Wintermint Five Whitening Formula Anticavity
FDA Label NDC 50001-121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Level Oral Care, Llc for the product Level Wintermint Five Whitening Formula Anticavity (NDC 50001-121). 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, indications & usage, otc - purpose, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Purpose
Anticaries
Otc - Purpose
Uses:
Aids in the prevention of dental cavities.
Warnings
WARNING
Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Dosage & Administration
DIRECTIONS
Adults and children 2 years of age and older:
Apply Level Toothpaste on to a soft bristle toothbrush. Brush 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 Ingredient
Inactive Ingredients
Calcium Carbonate, Purified Water, Xylitol, Sorbitol, Glycerin, Sodium Bicarbonate, Cellulose Gum, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, Tetrasodium Pyrophosphate, Sodium Benzoate, Sodium Saccharin
Other
Xylitol
Natural Enamel protection
True protection with fluoride
Ultra concentrated whitening agents
Active stain removal
Invigorating winter mint
enamel guard with pH stabilizers
Distributed by
Level Oral Care, LLC
Jacksonville, FL 32246
www.leveloralcare.com
Product of MY
Package Label.Principal Display Panel
Level
Wintermint Five
Whitening Formula
Anticavity Toothpaste
perfect your smile
NET WT. 5.0 OZ (141.7G)
Xylitol
natural enamel protection
True protection with fluoride
Ultra concentrated whitening agents
Active stain removal
Invigorating winter mint
Enamel Guard with pH stabilizers
ACTIVE INGREDIENT:
Sodium monofluorophosphate 0.76%
USES:
Aids in the prevention of dental cavities
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. Instruct children under 6 years of age 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
WARNINGS
Keep out of reach of children under 6 years of age. Do not swallow. if more than used from brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Distributed by:
Level Oral Care, LLC
Jacksonville, FL 32246
www.leveloralcare.com
Toothpasteprincipal (Wintermint Pdp)
Toothpastedrugpanel (Wintermint Panel)
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