PROSKI ZINCO SKIN PROTECTANT
Zinc Oxide Ointment
Approved
Approval ID
2cb7f314-beb4-e57f-e063-6394a90ad3ef
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 18, 2025
Manufacturers
FDA
PHARMAMED USA INC
DUNS: 065607328
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ZINC OXIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84289-119
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 18, 2025
FDA Product Classification
INGREDIENTS (5)
ZINC OXIDEActive
Quantity: 200 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT