Calamine
Good Sense 063.001/063AA Calamine Lotion
Approved
Approval ID
256bd1d4-fd50-408f-9aee-84f218bb4971
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Perrigo Direct, Inc.
DUNS: 076059836
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FERRIC OXIDE RED
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75981-063
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
FERRIC OXIDE RED
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (6)
BENTONITEInactive
Code: A3N5ZCN45C
Classification: IACT
CALCIUM HYDROXIDEInactive
Code: PF5DZW74VN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERRIC OXIDE REDActive
Quantity: 8 mg in 1 mL
Code: 1K09F3G675
Classification: ACTIB
ZINC OXIDEActive
Quantity: 8 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB