Betadine
Povidone-iodine, 5%
Approved
Approval ID
c927c742-ee92-459b-a8cf-cc2a791d596b
Product Type
OTC ANIMAL DRUG LABEL
Effective Date
Apr 18, 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 Code67618-155
Product Classification
G
Generic Name
Povidone-iodine
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (4)
Povidone-IodineActive
Quantity: 5 mg in 1 mL
Code: 85H0HZU99M
Classification: ACTIM
C12-15 Pareth-9Inactive
Code: H3ZIY6WP1R
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 4/18/2025
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/18/2025
VETERINARY INDICATIONS SECTION
LOINC: 50745-9Updated: 4/18/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/18/2025
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 4/18/2025
OTC - WHEN USING SECTION
LOINC: 50567-7Updated: 4/18/2025
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 4/18/2025
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 4/18/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/18/2025
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 4/18/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/18/2025
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 4/18/2025