Aplicare
1013 Aplicare Hydrogen Peroxide 3% Solution
Approved
Approval ID
0b3e5df6-03c8-3880-e063-6394a90a1cdc
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
Aplicare Products LLC
DUNS: 081054904
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrogen Peroxide
PRODUCT DETAILS
NDC Product Code52380-1013
Application NumberM003
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateApril 18, 2025
Generic NameHydrogen Peroxide
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROGEN PEROXIDEActive
Quantity: 3 mL in 100 mL
Code: BBX060AN9V
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/18/2025
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 4/18/2025
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/18/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/18/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/18/2025
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 4/18/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/18/2025
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/18/2025