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NDC 00699-0203-01 Buckleys Formo Cresol 350 mg/g Details

Buckleys Formo Cresol 350 mg/g

Buckleys Formo Cresol is a DENTAL LIQUID in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dentsply LLC, Professional Division Trading as "Sultan Healthcare". The primary component is CRESOL.

Product Information

NDC	00699-0203
Product ID	0699-0203_fa4df247-36e9-4c18-895b-88bdc468f716
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Buckleys Formo Cresol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cresol
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	LIQUID
Route	DENTAL
Active Ingredient Strength	350
Active Ingredient Units	mg/g
Substance Name	CRESOL
Labeler Name	Dentsply LLC, Professional Division Trading as "Sultan Healthcare"
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00699-0203-01 (00699020301)

Pricing Information	N/A
NDC Package Code	0699-0203-01
Billing NDC	00699020301
Package	33.57 g in 1 BOTTLE, GLASS (0699-0203-01)
Marketing Start Date	1963-02-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 79ad21fe-93cb-49a5-876c-eea77911f469 Details

SPL UNCLASSIFIED SECTION

DIRECTIONS FOR USE

REF – 10203 – Buckley's Formocresol – 1oz/30mL

NPN number: Buckley's Formocresol - 00470155

For dental use only.

1. DESCRIPTION

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 Buckley's 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.
Buckley's 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

Manufactured for:

Sultan Healthcare

1301 Smile Way • York, PA 17404-0807 • USA

Toll Free: 800-637-8582 • Phone: 201-871-1232

Fax: 201-871-0321 • www.sultanhealthcare.com

Made in the USA

0010601DF, R1-080714

Principal Display Panel - 30 mL bottle

INGREDIENTS AND APPEARANCE

BUCKLEYS FORMO CRESOL

cresol liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0699-0203
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CRESOL (UNII: GF3CGH8D7Z) (CRESOL - UNII:GF3CGH8D7Z)	CRESOL	350 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
FORMALDEHYDE (UNII: 1HG84L3525)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0699-0203-01	33.57 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/19/1963

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		02/19/1963

Labeler - Dentsply LLC, Professional Division Trading as "Sultan Healthcare" (167087753)

Name	Address	ID/FEI	Business Operations
Establishment
Dentsply Caulk		083235549	MANUFACTURE(0699-0203)

Revised: 1/2022

Document Id: fa4df247-36e9-4c18-895b-88bdc468f716

Set id: 79ad21fe-93cb-49a5-876c-eea77911f469

Version: 3

Effective Time: 20220118

Search by Drug Name or NDC

NDC 00699-0203-01 Buckleys Formo Cresol 350 mg/g Details

Buckleys Formo Cresol 350 mg/g

Product Information

Package

Package Images

NDC 00699-0203-01 (00699020301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 79ad21fe-93cb-49a5-876c-eea77911f469 Details

SPL UNCLASSIFIED SECTION

1. DESCRIPTION

2. INDICATIONS

3. CONTRAINDICATIONS

4. PRECAUTIONS

5. WARNINGS

6. DOSAGE AND ADMINISTRATION

7. STORAGE

SPL UNCLASSIFIED SECTION

Principal Display Panel - 30 mL bottle

INGREDIENTS AND APPEARANCE

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