Dti Apf - Strawberry

Dti Apf - Strawberry
SPL v3
SPL
SPL Set ID efe3646d-9eb1-4a49-aeb4-c4c224056851
Route
DENTAL
Published
Effective Date 2015-04-17
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.9 mg)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-04-01

Description

Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times a year.

Indications and Usage

Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times a year.

Dosage and Administration

After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes.

Contraindications

Hypersensitivity to fluoride.

Adverse Reactions

Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

How Supplied

A gel, one bottle contains up to 68 individual applications. Store at controlled room temperature 20°- 25°C (68°-77°F). Do not allow to freeze.


Medication Information

Indications and Usage

Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times a year.

Dosage and Administration

After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes.

Contraindications

Hypersensitivity to fluoride.

Adverse Reactions

Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

How Supplied

A gel, one bottle contains up to 68 individual applications. Store at controlled room temperature 20°- 25°C (68°-77°F). Do not allow to freeze.

Description

Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times a year.

Warning:

Keep out of reach of children. Do not swallow.

If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. Contains FD&C Red No. 40.

Precautions:

For professional use only. This product is not intended for home or unsupervised consumer use. Repeated use may cause dulling of porcelain and ceramic restorations.

How Supplied:

A gel, one bottle contains up to 68 individual applications. Store at controlled room temperature 20°- 25°C (68°-77°F).

Do not allow to freeze.

Adverse Reactions:

Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

Contraindications:

Hypersensitivity to fluoride.

Active Ingredients:

1.23% w/w Fluoride Ion (0.79% from Sodium Fluoride and 0.44% from Hydrogen Fluoirde) in 0.1 Molar Phosphoric Acid.

DENTAL TECHNOLOGIES

LINCOLNWOOD, ILLINOIS 60712 USA

www.dentaltech.com

Questions or Comments?

Call: 1-800-835-0885 (US) or 1-847-677-5500

PM-5097 Rev002

Indications and Usage:

Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times a year.

Principal Display Panel

DENTAL TECHNOLOGIES

www.dentaltech.com

ALPHA-PRO® APF

TOPICAL GEL

60 SECOND TREATMENT

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

Rx Only

Strawberry

REF No. 009-4201-002

NET WEIGHT: 17.5 oz. (497g)

Dosage and Administration:

After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes.


Structured Label Content

Warning:

Keep out of reach of children. Do not swallow.

If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. Contains FD&C Red No. 40.

Precautions:

For professional use only. This product is not intended for home or unsupervised consumer use. Repeated use may cause dulling of porcelain and ceramic restorations.

How Supplied:

A gel, one bottle contains up to 68 individual applications. Store at controlled room temperature 20°- 25°C (68°-77°F).

Do not allow to freeze.

Adverse Reactions:

Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

Contraindications:

Hypersensitivity to fluoride.

Active Ingredients:

1.23% w/w Fluoride Ion (0.79% from Sodium Fluoride and 0.44% from Hydrogen Fluoirde) in 0.1 Molar Phosphoric Acid.

DENTAL TECHNOLOGIES

LINCOLNWOOD, ILLINOIS 60712 USA

www.dentaltech.com

Questions or Comments?

Call: 1-800-835-0885 (US) or 1-847-677-5500

PM-5097 Rev002

Indications and Usage:

Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times a year.

Principal Display Panel

DENTAL TECHNOLOGIES

www.dentaltech.com

ALPHA-PRO® APF

TOPICAL GEL

60 SECOND TREATMENT

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

Rx Only

Strawberry

REF No. 009-4201-002

NET WEIGHT: 17.5 oz. (497g)

Dosage and Administration:

After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes.


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