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UREA

Urea Lotion 40%

Approved
Approval ID

cb6ddbfc-ea6a-0ddc-e053-2995a90aedc4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 6, 2023

Manufacturers
FDA

Bantry Pharma, LLC

DUNS: 117871480

Products 1

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

UREA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code81542-201
Product Classification
G
Generic Name
UREA
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 6, 2023
FDA Product Classification

INGREDIENTS (1)

UREAActive
Quantity: 400 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB

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UREA - FDA Drug Approval Details