Precaine (Topical Anesthetic Gel) Gel [Pascal Company, Inc.] -

PRECAINE (TOPICAL ANESTHETIC GEL) GEL [PASCAL COMPANY, INC.]
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NDC	10866-0062-1
Set ID	13c66e6e-b617-1cf3-e054-00144ff88e88
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	Pascal Company, Inc.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number

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DOSAGE FORMS & STRENGTHS

Contains: Lidocaine 8%, Dibucaine 0.8%

in a flavored aqueous base.

Net Contents 30g
DOSAGE & ADMINISTRATION
Application Directions:
- For topical use only
- For best results apply to previously dried oral mucosa with cotton swab or similar applicator for adequate control of pain.
- Removal of excess saliva during application minimizes dilution of the anesthetic and permits maximum penetration.
- Not more than one ounce (28g) per patient should be applied during a 24 hour period.
WARNINGS

Recommended dosage should not be exceeded due to possible side effects. Keep out of the reach of children. For professional use only. Do not use in the eyes. Avoid swallowing.
CONTRAINDICATIONS

Precaine is contraindicated in patients with known hypersensitivity to amine or quinoline type anesthetics.
OTHER SAFETY INFORMATION

For product MSDS information please go to www.pascaldental.com or contact Pascal directly.
PRINCIPAL DISPLAY PANEL

Precaine

Topical Anesthetic Gel for oral use

Strawberry

INGREDIENTS AND APPEARANCE

PRECAINE
topical anesthetic gel gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	80 mg in 1 g
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)	DIBUCAINE	8 mg in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10866-0062-1	30 g in 1 JAR; Type 0: Not a Combination Product	08/01/2000

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		08/01/2000

Labeler - Pascal Company, Inc. (009260217)

Registrant - Alexia Petropoulos (009260217)

Name	Address	ID/FEI	Business Operations
Establishment
Pascal Company, Inc.		009260217	manufacture(10866-0062)

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