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Avant Oral Rinse Prescribing Information

Package insert / product label
Generic name: sodium fluoride
Dosage form: dental liquid
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on May 31, 2023.

Indications and Usage for Avant Oral Rinse

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 Forms and Strengths

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/Side Effects

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

Avant Oral Rinse 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 is Avant Oral Rinse supplied

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

20201103_53045_267

AVANT
sodium fluoride liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-267
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 g in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Color Score
ShapeSize
FlavorSPEARMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-267-641.9 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/22/2021
Labeler - Dharma Research, Inc. (078444642)
Registrant - Dharma Research, Inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, Inc.078444642manufacture(53045-267)