FDA.reportPublic FDA data

Povidone Iodine

Manufacturer
Dr Radows
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:25

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Indications and uses

for the treatment of: minor wounds infections kills bacteria promptly

Dosage and administration

apply directly to affected area may be bandaged

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine USP10% w/w (available iodine 1%)

Purpose

OTC - PURPOSE SECTION

Antiseptic-germicidal

Uses

INDICATIONS & USAGE SECTION

for the treatment of:

  • minor wounds
  • infections
  • kills bacteria promptly

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • redness, irritation or swelling occurs or pain persists

Keep this and all drugs out of the 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

  • apply directly to affected area
  • may be bandaged

Other information

SPL UNCLASSIFIED SECTION

  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.
  • For control no. and expiration date, see carton and/or crimp of tube.
  • Will not stain natural fabrics.
  • Protect from freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, PEG-6, PEG-32, propylene glycol

Questions?

OTC - QUESTIONS SECTION

call (386) 414- 1809

Distributed by Dr Radow's PO Box 952 Deland FL, 32721-0952  

Principal Display Panel – 1 oz. Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Doctor Radow                  NDC 81584-1102-1

POVIDINE – IODINE 10%

First Aid Antiseptic Ointment

AVAILABLE IODINE 1% 

NET WT. 1 OZ (28.35 g)

Principal Display Panel – 1 oz. TubePrincipal Display Panel – 1 oz. Tube

Principal Display Panel – 1 oz. TubePrincipal Display Panel – 1 oz. Tube

Principal Display Panel – 1 oz. Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Doctor Radow                     NDC 81584-1102-1

Povidone Iodine 10%

First Aid Antiseptic Ointment

Available Iodine 1%

NET WT 1 OZ (28.35g)

Principal Display Panel – 1 oz. CartonPrincipal Display Panel – 1 oz. Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312563povidone-iodine 10 % Topical OintmentPSN2
312563povidone-iodine 0.1 MG/MG Topical OintmentSCD2
312563povidone-iodine 10 % (equal to 1 % available iodine) Topical OintmentSY2
312563povidone-iodine 10 % Topical OintmentSY2

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
81584-1102-1Povidone Iodine1 in 1 CARTONOINTMENT12
81584-1102-1Povidone Iodine28.35 g in 1 TUBEOINTMENT28.352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81584-1102POVIDONE IODINE (POVIDONE-IODINE) OINTMENT [DR RADOWS]2Current NDC, Legacy NDC, 2 package rows20231031_58e1757c-45ce-455e-bd64-a9e99cd3680f.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81584-110281584-1102-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
Povidone IodinePOVIDONE-IODINEDr Radows58e1757c-45ce-455e-bd64-a9e99cd3680f2023-10-30WarningsExact identifier
ndc (package): 81584-1102-1
ndc (product): 81584-1102
ndc11 (package): 81584110201
spl id: 7bad4367-4449-46e9-8e5a-61296bc466fd
spl set id: 58e1757c-45ce-455e-bd64-a9e99cd3680f

Reported adverse events (FAERS/openFDA)#

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