FDA.reportPublic FDA data

Sunmark Povidone-Iodine 10% Topical Solution

Manufacturer
Strategic Sourcing Services LLC | Pharma Nobis, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:04:59

Label at a glance#

Productsunmark Povidone-Iodine Topical
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and uses

First aid antiseptic to prevent infection in minor cuts, burns.

Dosage and administration

Clean the affected area Apply a small amount on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Storage and handling

Store at room temperature, 20-25 0 C (68-77 0 F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10%  (*Equivalent to 1% titratable Iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid antiseptic to prevent infection in minor cuts, burns.

Warnings

WARNINGS SECTION

For external use only.

Do not:

OTC - DO NOT USE SECTION

  • use in the eyes.
  • use longer than 1 week unless directed by a doctor.
  • use on individuals who are allergic or sensitive to iodine.
  • apply over large areas of the body.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • condition persists or gets worse.
  • irritation and redness develop and persist for more than 72 hours.

Ask a doctor in case of:

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Apply a small amount on the area 1 to 3 times daily.
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature, 20-25 0 C (68-77 0 F).

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric Acid, Disodium Phosphate, Glycerin, Nonoxynol-9, Sodium Hydroxide and Purified Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO BETADINE ACTIVE INGREDIENT*   sunmark povidone-iodine 10% Topical Solution  FIRST AID ANTISEPTIC  16 FL OZ (PT) 473mL  *This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark Betadine

sunmark Povidone-Iodine 10% Topical Solution 8oz (49348-622-37) | sunmark Povidone-Iodine 10% Topical Solution 16oz (49348-622-38)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povidone 8 ozPovidone 8 ozPovidone 16 ozPovidone 16 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN9
312564povidone-iodine 100 MG/ML Topical SolutionSCD9
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY9

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
49348-622-37sunmark Povidone-Iodine Topical237 mL in 1 BOTTLESOLUTION2379
49348-622-38sunmark Povidone-Iodine Topical473 mL in 1 BOTTLESOLUTION4739

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-622SUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [STRATEGIC SOURCING SERVICES LLC]9Current NDC, Legacy NDC, 2 package rows20231220_acc349d6-2875-4814-aa6e-828fffec7f07.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-622-37ML - Milliliter49348-62262bff34c-23b1-4c58-ace5-4de9b5e144bd12012-07-24
49348-622-38ML - Milliliter49348-62204df9a48-79d9-41a5-9034-108ab993296312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M2
POVIDONE-IODINEACTIVE MOIETY85H0HZU99M2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-62249348-622-37, 49348-622-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sunmark Povidone-Iodine TopicalPOVIDONE-IODINEStrategic Sourcing Services LLCacc349d6-2875-4814-aa6e-828fffec7f072023-12-19WarningsExact identifier
ndc (package): 49348-622-37
ndc (package): 49348-622-38
ndc (product): 49348-622
ndc11 (package): 49348062237
ndc11 (package): 49348062238
spl id: 0ce5be01-e0b9-7245-e063-6294a90acccf
spl set id: acc349d6-2875-4814-aa6e-828fffec7f07

Reported adverse events (FAERS/openFDA)#

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