Formo Cresol
FDA Label NDC 0699-0001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dshealthcare for the product Formo Cresol (NDC 0699-0001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, 1. description, 2. indications, 3. contraindications, 4. precautions, 5. warnings, 6. dosage and administration, 7. storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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.

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)

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

  • 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.
  • 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.

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 (30 mL Bottle Label)

Principal Display Panel (30 mL Bottle Label)

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)

Principal Display Panel (1 Gallon Bottle Label)

Principal Display Panel (1 Gallon Bottle Label)

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