Avant Oral Rinse: Package Insert / Prescribing Information - Drugs.com

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# Avant Oral Rinse

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

Medically reviewed by Drugs.com. Last updated on Dec 22, 2022.

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 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 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

## 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 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 LABEL | 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
1 | NDC:53045-267-64 | 1.9 L in 1 BOTTLE, PUMP

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)

Dharma Research, Inc.

## More about Avant Oral Rinse (fluoride topical)

- Side effects
- Dosage information
- During pregnancy
- Drug class: mouth and throat products

### Professional resources

- Prescribing Information

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