Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Consumer Product Partners, LLC
119091520
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Consumer Product Partners, LLC
Consumer Product Partners, LLC
Consumer Product Partners, LLC
119091514
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isopropyl alcohol
Product Details
NDC Product Code
11344-845Application Number
M003Marketing Category
OTC Monograph Drug (C200263)Route of Administration
TOPICALEffective Date
April 8, 2025FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022YClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
Isopropyl alcoholActive
Code: ND2M416302Class: ACTIBQuantity: 70 mL in 100 mL