- SPL UNCLASSIFIED SECTION
- 1. DESCRIPTION
- 2. INDICATIONS
- 3. CONTRAINDICATIONS
- 4. PRECAUTIONS
- 5. WARNINGS
-
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
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
Sultan®
REF 10601
NPN 00470236Formo 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 4T5Rx Only
For Dental Use OnlyLOT
EXPMade 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.comRx Only
For Dental Use OnlyLOT
EXPMade in USA
0010604LA (R 7/23/09) -
INGREDIENTS AND APPEARANCE
FORMO CRESOL
cresol liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cresol (UNII: GF3CGH8D7Z) (Formaldehyde - UNII:1HG84L3525) Formaldehyde 485 mg in 1 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0412 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cresol (UNII: GF3CGH8D7Z) (Formaldehyde - UNII:1HG84L3525) Formaldehyde 485 mg in 1 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Business Operations DENTSPLY Caulk 083235549 MANUFACTURE