SPL v2
SPL
SPL Set ID 184bbe52-3909-45f6-b4d0-fe7849fabc1c
Route
DENTAL
Published
Effective Date 2021-01-25
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2 g)
Inactive Ingredients
Water Sodium Benzoate Saccharin Sodium Xylitol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-01-22

Description

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.

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.

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.

Contraindications

Avoid use in patients with known hypersensitivity to fluoride

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

How 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.


Medication Information

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.

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.

Contraindications

Avoid use in patients with known hypersensitivity to fluoride

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

How 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.

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.

Dosage Form and Strength

Liquid containing 2% sodium fluoride

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


Structured Label Content

Description (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

Adverse Reactions (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

Contraindications (CONTRAINDICATIONS)

Avoid use in patients with known hypersensitivity to fluoride

How Supplied/storage (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.

Indications and Usage (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 (DOSAGE FORM AND STRENGTH)

Liquid containing 2% sodium fluoride

Warnings and Precautions (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.

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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