Diaper Rash
Comforts_Kroger 020.002/020AC-AD Diaper Rash Ointment 40% Zinc Oxide
Approved
Approval ID
fcffbe1f-79b8-451a-9384-19533b81d8c8
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 24, 2025
Manufacturers
FDA
Kroger Co
DUNS: 006999528
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 Code30142-020
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 24, 2025
FDA Product Classification
INGREDIENTS (9)
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
COD LIVER OILInactive
Code: BBL281NWFG
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ZINC OXIDEActive
Quantity: 400 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB