FDA Product

Precaine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Precaine

FDA Product Code

10866-0062

Regulatory Information

NDC Product Code

10866-0062

Effective Date

December 19, 2022

FDA Title

Precaine Anesthetic Gel

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

6

Company Information

ManufacturerPascal Company, Inc.

DUNS Number

009260217

Active Ingredients

Quantity: 80 mg in 1 g

Code: 98PI200987

Class Code: ACTIB

Quantity: 8 mg in 1 g

Code: L6JW2TJG99

Class Code: ACTIB

Active Moieties

DIBUCAINE

Code: L6JW2TJG99

LIDOCAINE

Code: 98PI200987

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