Keratex
Approved
Approval ID
d19063d2-0fec-43d3-93b2-cffbb361ab4d
Product Type
OTC ANIMAL DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Penleigh Irving Ltd
DUNS: 505992479
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
microcrystalline wax, rosin, turpentine and sulfur
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27426-070
Product Classification
G
Generic Name
microcrystalline wax, rosin, turpentine and sulfur
Product Specifications
Route of AdministrationTopical
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (4)
MICROCRYSTALLINE WAXActive
Quantity: 103.31 g in 147 g
Code: XOF597Q3KY
Classification: ACTIB
ROSINActive
Quantity: 35.11 g in 147 g
Code: 88S87KL877
Classification: ACTIB
TURPENTINEActive
Quantity: 7.11 g in 147 g
Code: XJ6RUH0O4G
Classification: ACTIB
SULFURActive
Quantity: 1.44 g in 147 g
Code: 70FD1KFU70
Classification: ACTIB