Zepol Topical Analgesic
Zepol Topical Analgesic Ointment
Approved
Approval ID
ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Laboratorios Zepol S.A.
DUNS: 853070985
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Camphor, Menthol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55715-001
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Camphor, Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (6)
TURPENTINEInactive
Code: XJ6RUH0O4G
Classification: IACT
EUCALYPTOLInactive
Code: RV6J6604TK
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
THYME OILInactive
Code: 2UK410MY6B
Classification: IACT
CAMPHOR (SYNTHETIC)Active
Quantity: 6.55 g in 100 g
Code: 5TJD82A1ET
Classification: ACTIB
MENTHOLActive
Quantity: 6.55 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB