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HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%

HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%

Approved
Approval ID

89036512-64f6-224b-e053-2a95a90a8068

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 16, 2019

Manufacturers
FDA

Sincerus Florida, LLC

DUNS: 080105003

Products 1

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

HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72934-2097
Product Classification
G
Generic Name
HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 16, 2019
FDA Product Classification

INGREDIENTS (3)

UREAActive
Quantity: 20 g in 100 g
Code: 8W8T17847W
Classification: ACTIB
TACROLIMUSActive
Quantity: 0.1 g in 100 g
Code: WM0HAQ4WNM
Classification: ACTIM
HYALURONATE SODIUMActive
Quantity: 1 g in 100 g
Code: YSE9PPT4TH
Classification: ACTIB

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HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20% - FDA Drug Approval Details