Formo Cresol

Dosage Form: liquid
Formocresol/Buckley's Formocresol

DIRECTIONS FOR USE

REF – 10606 – Formocresol – 1oz/30mL

REF – 10203 – Buckley's Formocresol – 1oz/30mL

NPN number: Formocresol – 00470236

NPN number: Buckley's Formocresol - 00470155

For dental use only.

USA: Rx only.

1. DESCRIPTION

Formocresol: 48.5% formaldehyde, 48.5% cresol, 3% glycerine. Buckley's Formocresol: 19% formaldehyde, 35% cresol, 17.5% gylcerine.

2. INDICATIONS

Indicated as a disinfectant and devitalizing solution used as part of endodontic treatment.

3. CONTRAINDICATIONS

This product should not be used with individuals with known sensitivities to formaldehyde or cresol. This product should not be used with individuals who are pregnant or suspected to be pregnant without a prior physician consultation.

4. PRECAUTIONS

This product can cause severe burns of skin and mucosa. Take precautions protect skin, mucosa and eyes during use.

5. WARNINGS

Do not swallow. Do not allow material to come into contact with intact skin or mucosa. Wear eye protection when handling. Ensure proper tooth isolation, including rubber dam when applying. Keep out of reach of children. For professional dental use only.

6. DOSAGE AND ADMINISTRATION

1. Intracanal disinfection in permanent teeth: Isolate the tooth with a rubber dam. Clean, de-bride and instrument the canals. Rinse and dry the canal spaces. Moisten a small cotton pellet with formocresol. Blot or wring any excess liquid from the pellet. Place the cotton pellet in the pulp chamber and seal the access hole with a temporary filling material. Recall the patient after a minimum of 48 hours and remove the pellet. Complete the endodontic treatment and restore.


2. Formocresol pulpotomy in primary teeth: Isolate the tooth with a rubber dam. Remove visible caries. Remove the coronal pulp with an excavator or bur leaving the radicular pulp. Achieve hemostasis. Moisten small cotton pellets with fomocresol. Blot or wring any excess liquid from the pellet. Place the pellets directly on the radicular pulp stumps for 5 minutes. Place a base or a core in the tooth and restore.

7. STORAGE

Store between 59°-86°F (15°-30°C). Protect from freezing.

SultanHealthcare

411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601

Toll Free: 800-637-8582 • Phone: 201-871-1232

Fax: 201-871-0321 • www.sultanhealthcare.com

Made in the USA

Form #0010601DF (R 7/22/09)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Sultan®

REF 10601

NPN 00470236

Formo Cresol

Net Contents:

1 fl.oz. (30mL)

Warning: Corrosive. Consult MSDS for more information.

Solution may cloud below 50°F. Store at room temperature. Keep from freezing.

Contains: Formaldehyde 48.5%, Cresol 48.5%

Manufactured for: SultanHealthcare

411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601 • Toll Free: 800-637-8582 • Phone: 201-871-1232

Fax: 201-871-0321 • www.sultanhealthcare.com • Imp. by VDI Healthcare, Brampton, Ontario L6W 4T5

Rx Only

For Dental Use Only

LOT

EXP

Made in USA

0010601LA (R 7/23/09)

PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

Sultan®

REF 10604

Formo Cresol

Net Contents: 1 gallon

Warning: Corrosive. Consult MSDS for more information.

Solution may cloud below 50°F. Store at room temperature. Keep from freezing.

Contains: Formaldehyde 48.5%, Cresol 48.5%

Manufactured for:

SultanHealthcare

411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601

Toll Free: 800-637-8582 • Phone: 201-871-1232

Fax: 201-871-0321 • www.sultanhealthcare.com

Rx Only

For Dental Use Only

LOT

EXP

Made in USA

0010604LA (R 7/23/09)

Formo Cresol  cresol  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0699-0001 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cresol (Formaldehyde) Formaldehyde 485 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Glycerin

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0699-0001-01 33.57 g In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/19/1963

Formo Cresol  cresol  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0699-0412 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cresol (Formaldehyde) Formaldehyde 485 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Glycerin

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0699-0412-01 4292.19 g In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/19/1963

Labeler - DSHealthcare (056296981)

Establishment
Name	Address	ID/FEI	Operations
DENTSPLY Caulk		083235549	MANUFACTURE

Revised: 02/2010DSHealthcare