FDA Label for Avant
View Indications, Usage & Precautions
Avant Product Label
The following document was submitted to the FDA by the labeler of this product Dharma Research, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications And Usage
This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.
Dosage Form And Strength
Liquid containing 2% sodium fluoride
Contraindications
Avoid use in patients with known hypersensitivity to fluoride
Warnings And Precautions
Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. Use in children less than 6 years of age requires special supervision to prevent swallowing. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help right away.
Adverse Reactions
To report suspected adverse reactions, contact Dharma Research, Inc. at 1-877-833-3725 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Description
Avant Fluoride Oral Rinse is a flavored, pH neutral 2.0% sodium fluoride treatment rinse that aids in the prevention of dental decay.
ACTIVE INGREDIENT: Sodium Fluoride, 2.0%
INACTIVE INGREDIENTS: Flavor, Water, Sodium Benzoate, Sodium Citrate, Saccharin Sodium, Xylitol
How Supplied/Storage
64 fluid ounces (1.9 L) in a plastic bottle with dispensing pump included. Store at room temperature 59-86°F (15-30°C). Protect from freezing.
Avant Sodium Fluoride Oral Rinse
2.0% Neutral Sodium Fluoride
Rx Only
Dye Free
With Xylitol
Gluten Free
64 fl. oz. (1.9 L)
Spearmint
Manufactured by:
Dharma Research, Inc., 5220 NW 72nd Avenue, Unit 15, Miami, FL, 33166
1-877-833-3725
www.avant-dental.com
Label Revision A, 11/03/2020
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