PROSKI SOOTHE
CALAMINE SKIN PROTECTANT CREAM
Approved
Approval ID
2c7b23a1-76cb-095e-e063-6294a90ac6f2
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.
Menthol, Zinc Oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84289-234
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol, Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 18, 2025
FDA Product Classification
INGREDIENTS (10)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
THYMOLInactive
Code: 3J50XA376E
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
ZINC OXIDEActive
Quantity: 21 g in 100 g
Code: SOI2LOH54Z
Classification: ACTIB
MENTHOLActive
Quantity: 0.44 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT