Betadine
BETADINE® Solution10% Povidone-iodine
Approved
Approval ID
1b1e224c-8c00-46ea-9bdd-020a9b45321d
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
Atlantis Consumer Healthcare, Inc.
DUNS: 118983925
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
POVIDONE-IODINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67618-150
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
POVIDONE-IODINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (7)
POVIDONE-IODINEActive
Quantity: 10 mg in 1 mL
Code: 85H0HZU99M
Classification: ACTIM
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATEInactive
Code: BWZ7K44R51
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NONOXYNOL-9Inactive
Code: 48Q180SH9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/22/2023
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 3/5/2021
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 3/5/2021
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 3/5/2021
WARNINGS SECTION
LOINC: 34071-1Updated: 3/5/2021
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 3/5/2021
OTC - ASK DOCTOR/PHARMACIST SECTION
LOINC: 50568-5Updated: 3/5/2021
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 3/5/2021
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 3/5/2021
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 3/5/2021
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 3/5/2021
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 3/5/2021
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 3/5/2021