Formo Cresol: Package Insert / Prescribing Information - Drugs.com

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# Formo Cresol

Package insert / prescribing information
Generic name: cresol liquid
Dosage form: liquid

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.

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 LABEL | Item Code (Source) | NDC: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 |

Packaging
# | Item Code | Package Description
1 | NDC:0699-0001-01 | 33.57 g in 1 BOTTLE, GLASS

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 LABEL | Item Code (Source) | NDC: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 |

Packaging
# | Item Code | Package Description
1 | NDC:0699-0412-01 | 4292.19 g in 1 BOTTLE, GLASS

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

DSHealthcare

Medical Disclaimer