{"adverse_reactions":["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."],"contraindications":["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."],"description":["1. DESCRIPTION Formocresol: 48.5% formaldehyde, 48.5% cresol, 3% glycerine. Buckley's Formocresol: 19% formaldehyde, 35% cresol, 17.5% gylcerine."],"effective_time":"20100204","id":"b2917c26-a3fc-48a9-b5f0-1d62fe15af74","indications_and_usage":["2. INDICATIONS Indicated as a disinfectant and devitalizing solution used as part of endodontic treatment."],"openfda":{},"package_label_principal_display_panel":["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: Sultan Healthcare 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 - 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: Sultan Healthcare 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"],"precautions":["4. PRECAUTIONS This product can cause severe burns of skin and mucosa. Take precautions protect skin, mucosa and eyes during use."],"set_id":"6989bddc-910e-47e6-aa8f-619a330e81b8","spl_product_data_elements":["Formo Cresol Cresol Cresol Formaldehyde Glycerin Formo Cresol Cresol Cresol Formaldehyde Glycerin"],"spl_unclassified_section":["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.","Sultan Healthcare 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)"],"storage_and_handling":["7. STORAGE Store between 59°-86°F (15°-30°C). Protect from freezing."],"version":"1","warnings":["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."]}