Avant

Manufacturer
Dharma Research, Inc.
Effective date
2021-01-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:35:11

Label at a glance#

ProductAvant
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

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.

Storage and handling

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.

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

DOSAGE FORMS & STRENGTHS SECTION

Liquid containing 2% sodium fluoride

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Avoid use in patients with known hypersensitivity to fluoride

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

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

ADVERSE REACTIONS SECTION

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

DESCRIPTION SECTION

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

HOW SUPPLIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2.0% Neutral Sodium Fluoride

Rx Only

Dye Free

With Xylitol

Gluten Free

64 fl. oz. (1.9 L)

Fruit Punch

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_26820201103_53045_268

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251960sodium fluoride 2 % Oral RinsePSN2
251960sodium fluoride 20 MG/ML MouthwashSCD2
251960sodium fluoride 2 % Oral RinseSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53045-268-64Avant1.9 L in 1 BOTTLE, PUMPLIQUID1.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53045-268AVANT (SODIUM FLUORIDE) LIQUID [DHARMA RESEARCH, INC.]2Current NDC, Legacy NDC, 1 package rows20210126_4749dce1-c0b9-4737-8a30-85cd58aba21b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53045-26853045-268-64

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AvantSODIUM FLUORIDEDharma Research, Inc.4749dce1-c0b9-4737-8a30-85cd58aba21b2021-01-25Warnings, Adverse reactionsExact identifier
ndc (package): 53045-268-64
ndc (product): 53045-268
ndc11 (package): 53045026864
spl id: 78538c89-5afb-4316-a86a-1e5237d543e9
spl set id: 4749dce1-c0b9-4737-8a30-85cd58aba21b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.