FDA Label for Formo Cresol
View Indications, Usage & Precautions
Formo Cresol Product Label
The following document was submitted to the FDA by the labeler of this product Dshealthcare. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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 - 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)
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