drug facts

drug facts
SPL v1
SPL
SPL Set ID f35a7d34-0c33-4914-928e-2427949437b0
Route
topical
Published
Effective Date 2010-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
povidone-iodine (0.10 mg)
Inactive Ingredients
citric acid monohydrate glycerin sodium hydroxide water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2007-12-06
Purpose

Antiseptic

Description

Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

Medication Information

Warnings and Precautions



Warnings

For external use only.

Purpose

Antiseptic

Directions
  • Clean the affected area
  • Apply a small amount of this product to the area 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

Other Information
Store at room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients
citric acid, glycerin, Makon 8, purified water, sodium hydroxide
Description

Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

Use
First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Do Not
  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body

Section 42229-5



Section 50567-7



Section 50568-5



Section 53413-1



Section 53414-9



Active Ingredient

Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

Package Information

MEDIC®

NDC 50730-8230-1

*COMPARE TO THE ACTIVE

INGREDIENT IN BETADINE®

10% Topical Solution

Povidone

Iodine



For External Use Only



Helps prevent the risk of

infection in minor cuts,

scrapes and burns





8 FL OZ (236 mL)



Distributed by Winn-Dixie Stores, Inc.

Jacksonville, FL 32254

©2008 Winn-Dixie Stores, Inc.



Quality Guaranteed

1-866-WINN-DIXIE

www.winn-dixie.com



*This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark, Betadine®.







Ask A Doctor in Case Of
  • deep or puncture wounds
  • animal bites
  • serious burns

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Discontinue Use and Ask A Doctor
  • if condition persists or gets worse
  • for use longer than 1 week

Structured Label Content

Warnings and Precautions (34071-1)



Warnings (WARNINGS)

For external use only.

Purpose (PURPOSE)

Antiseptic

Directions (DIRECTIONS)
  • Clean the affected area
  • Apply a small amount of this product to the area 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

Other Information (OTHER INFORMATION)
Store at room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients (INACTIVE INGREDIENTS)
citric acid, glycerin, Makon 8, purified water, sodium hydroxide
Use (USE)
First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Do Not (Do not)
  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body

Section 42229-5 (42229-5)



Section 50567-7 (50567-7)



Section 50568-5 (50568-5)



Section 53413-1 (53413-1)



Section 53414-9 (53414-9)



Active Ingredient (ACTIVE INGREDIENT)

Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

Package Information (PACKAGE INFORMATION)

MEDIC®

NDC 50730-8230-1

*COMPARE TO THE ACTIVE

INGREDIENT IN BETADINE®

10% Topical Solution

Povidone

Iodine



For External Use Only



Helps prevent the risk of

infection in minor cuts,

scrapes and burns





8 FL OZ (236 mL)



Distributed by Winn-Dixie Stores, Inc.

Jacksonville, FL 32254

©2008 Winn-Dixie Stores, Inc.



Quality Guaranteed

1-866-WINN-DIXIE

www.winn-dixie.com



*This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark, Betadine®.







Ask A Doctor in Case Of (Ask a doctor in case of)
  • deep or puncture wounds
  • animal bites
  • serious burns

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Discontinue Use and Ask A Doctor (Discontinue use and ask a doctor)
  • if condition persists or gets worse
  • for use longer than 1 week

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.190357 · Updated: 2026-03-14T22:52:17.029964