Avant

AVANT- sodium fluoride liquid
Dharma Research, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

AVANT sodium fluoride liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-267 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2 g in 1 L

Inactive Ingredients Ingredient Name Strength WATER SODIUM BENZOATE SACCHARIN SODIUM XYLITOL

Product Characteristics Color Score Shape Size Flavor SPEARMINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53045-267-64 1.9 L in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/22/2021

Labeler — Dharma Research, Inc. (078444642)

Registrant — Dharma Research, Inc. (078444642)

Establishment
Name	Address	ID/FEI	Operations
Dharma Research, Inc.		078444642	manufacture (53045-267)

Revised: 01/2021 Dharma Research, Inc.