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Precaine

Precaine Anesthetic Gel

Approved
Approval ID

13c66e6e-b617-1cf3-e054-00144ff88e88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2022

Manufacturers
FDA

Pascal Company, Inc.

DUNS: 009260217

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Topical Anesthetic Gel

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10866-0062
Product Classification
G
Generic Name
Topical Anesthetic Gel
Product Specifications
Route of AdministrationBUCCAL, TOPICAL, DENTAL
Effective DateDecember 19, 2022
FDA Product Classification

INGREDIENTS (2)

LIDOCAINEActive
Quantity: 80 mg in 1 g
Code: 98PI200987
Classification: ACTIB
DIBUCAINEActive
Quantity: 8 mg in 1 g
Code: L6JW2TJG99
Classification: ACTIB

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Precaine - FDA Drug Approval Details