Label: FORMO CRESOL- cresol liquid

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 4, 2010

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  • 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

    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 - 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
  • INGREDIENTS AND APPEARANCE
    FORMO CRESOL 
    cresol liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cresol (UNII: GF3CGH8D7Z) (Formaldehyde - UNII:1HG84L3525) Formaldehyde485 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0001-0133.57 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    FORMO CRESOL 
    cresol liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0412
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cresol (UNII: GF3CGH8D7Z) (Formaldehyde - UNII:1HG84L3525) Formaldehyde485 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0412-014292.19 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    Labeler - DSHealthcare (056296981)
    Establishment
    NameAddressID/FEIBusiness Operations
    DENTSPLY Caulk083235549MANUFACTURE
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