FDA.reportPublic FDA data

BETADINE® Solution 10% Povidone-iodine

Manufacturer
Atlantis Consumer Healthcare, Inc.
Effective date
2026-01-21
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:34:33

Label at a glance#

ProductBetadine Solution
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Indications and uses

First aid to helpprevent infection in minor cuts scrapes burns

Dosage and administration

clean the affected area apply a small amount of product to the area 1 to 3 timesdaily may be covered with a sterile bandage if bandaged, let dry first

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid to helpprevent infection in minor

  • cuts
  • scrapes
  • burns

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body
  • if you are allergic to povidone-iodine or any other ingredientsin this preparation

Ask a doctor before useif you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • you need to use this product for more than 1 week

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, getmedical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of product to the area 1 to 3 timesdaily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, disodiumphosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

SPL UNCLASSIFIED SECTION

Dist.by:
Avrio Health L.P.
Stamford, CT 06901-3431

305541-0D

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BetadineSolution 8 fl oz Bottle
NDC: 67618-150-08

Betadine Solution Bottle
Betadine Solution Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
211108Betadine 10 % Topical SolutionPSN8
312564povidone-iodine 10 % Topical SolutionPSN8
211108povidone-iodine 100 MG/ML Topical Solution [Betadine]SBD8
312564povidone-iodine 100 MG/ML Topical SolutionSCD8
211108Betadine 10 % Topical SolutionSY8
211108Betadine 100 MG/ML Topical SolutionSY8
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY8

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130367618150085GTIN-13: 0367618150085
EAN-13: 0367618150085
GTIN-12: 367618150085
UPC-A: 367618150085
GTIN storage (14 digits): 00367618150085		bottle.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-150-08BetadineSolution237 mL in 1 BOTTLESOLUTION2378
67618-150-16BetadineSolution237 mL in 1 BOTTLESOLUTION2378
67618-150-16BetadineSolution2 in 1 PACKAGESOLUTION28
67618-150-18BetadineSolution177 mL in 1 BOTTLESOLUTION1778

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-150-01ML - Milliliter67618-150cbf42a3b-94e6-45b3-8f0a-04b5e5368e3a12012-07-24
67618-150-04ML - Milliliter67618-150f7938d5c-110a-4469-91f8-573515d9dfd712012-07-24
67618-150-05ML - Milliliter67618-1502305ff9f-102d-46ef-b57e-694761f7b23912012-07-24
67618-150-08ML - Milliliter67618-15052fde23f-ff3d-4a52-b509-0ec9b4903d7312012-07-24
67618-150-09ML - Milliliter67618-15080a38c53-91e3-4e4e-9cb5-33c65a08957d12012-07-24
67618-150-16ML - Milliliter67618-15030308f80-23ab-4424-9517-3bbae7e18bd712012-07-24
67618-150-17ML - Milliliter67618-15042227753-d583-4beb-9997-5294ff4e4d3a12012-07-24
67618-150-18ML - Milliliter67618-1501459d28f-7b2a-41dc-8aac-394b447ea60a12024-05-16
67618-150-32ML - Milliliter67618-1501727131b-d15f-4776-bbe0-21d146a0644712012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-15067618-150-08, 67618-150-18, 67618-150-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATEBWZ7K44R51IACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1b1e224c-8c00-46ea-9bdd-020a9b45321d2026-01-21WarningsExact identifier
ndc (package): 67618-150-16
ndc (package): 67618-150-08
ndc (package): 67618-150-18
ndc (product): 67618-150
ndc11 (package): 67618015016
ndc11 (package): 67618015018
ndc11 (package): 67618015008
spl id: b2020f1d-4f38-48e4-9642-ea027fbfb9c9
spl set id: 1b1e224c-8c00-46ea-9bdd-020a9b45321d
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
ndc (product): 67618-150

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.