FDA.reportPublic FDA data

Freskaro Povidone Iodine

Manufacturer
Pharma Nobis, LLC
Effective date
2026-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:46

Label at a glance#

ProductFreskaro Povidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure15 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For External Use Only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep puncture wounds
  • animal bites
  • serious burns

Stop use and consult a doctor if

OTC - STOP USE SECTION

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

When using this product do not

OTC - WHEN USING SECTION

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

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

store at room temperature, 20-25C (68-77F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions & comments?

OTC - QUESTIONS SECTION

1-833-551-0932

8 oz 2026 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Povidone 8 oz 2026Freskaro Povidone 8 oz 2026

16 oz 2026 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Povidone 16 oz 2026Freskaro Povidone 16 oz 2026

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN1
312564povidone-iodine 100 MG/ML Topical SolutionSCD1
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130382645325169GTIN-13: 0382645325169
EAN-13: 0382645325169
GTIN-12: 382645325169
UPC-A: 382645325169
GTIN storage (14 digits): 00382645325169		Freskaro Povidone Iodine 16 oz 4 14 2026.jpg
BarcodeEAN-130382645325985GTIN-13: 0382645325985
EAN-13: 0382645325985
GTIN-12: 382645325985
UPC-A: 382645325985
GTIN storage (14 digits): 00382645325985		Freskaro Povidone Iodine 8 oz 4 14 2026.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
82645-325-16Freskaro Povidone Iodine473 mL in 1 BOTTLE, PLASTICLIQUID4731
82645-325-98Freskaro Povidone Iodine237 mL in 1 BOTTLE, PLASTICLIQUID2371

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
82645-32582645-325-98, 82645-325-16

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freskaro Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLC4f711d3b-5ed6-5dd4-e063-6294a90afeaa2026-04-14WarningsExact identifier
ndc (package): 82645-325-16
ndc (package): 82645-325-98
ndc (product): 82645-325
ndc11 (package): 82645032516
ndc11 (package): 82645032598
spl id: 4f712266-5467-a9e2-e063-6294a90a7b1b
spl set id: 4f711d3b-5ed6-5dd4-e063-6294a90afeaa

Reported adverse events (FAERS/openFDA)#

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