Isopropyl alcohol
Swan 845.003/845AE 70% IPA with Wintergreen
Approved
Approval ID
bb0bb871-df30-4c2a-bcd9-b819b0d2f4d3
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
Consumer Product Partners, LLC
DUNS: 119091520
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isopropyl Alcohol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11344-845
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (6)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ISOPROPYL ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: ND2M416302
Classification: ACTIB