SPL v4
SPL
SPL Set ID 98be29e6-0c9b-22a6-e053-2995a90a9f8c
Route
TOPICAL
Published
Effective Date 2019-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Water Hydroxyethyl Cellulose (5000 Cps At 1%) Potassium Iodide Glycerin Anhydrous Citric Acid Sodium Hydroxide Nonoxynol-10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-02
Description

Povidone-Iodine USP 10%

Purpose

Antispetic

Medication Information

Purpose

Antispetic

Description

Povidone-Iodine USP 10%

Use

Antiseptic Skin Preparation

Warnings

For External Use Only

Directions
  • apply product to skin as needed
  • see product box for additional directions
Do Not Use
  • If allergic to Iodine
  • in the eyes
Active Ingredient

Povidone-Iodine USP 10%

Other Information
  • 1% titratable iodine
  • Avoid excessive heat
  • Store at room temperature
  • For hospital or professional use only
  • Not made with natural rubber latex
Inactive Ingredients

alkyl glucoside, anhydrous citric acid, aonoxynol-10, glycerin, hydroxyethyl cellulose, potassium iodine, sodium hydroxide, water

Stop Use and Ask Doctor If
  • infection occurs
  • redness, irritation or swelling develops
Keep Out of Reach of Children

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

Dukal Povidone Iodine Gel Swabstick

DUKAL™

CORPORATION

NDC 65517-0036-1

REF 899

Hold Upright and Tear Here

POVIDONE-IODINE

Gel Swabstick

Ready Gel 1X™

4" (10.2cm)

Saturated Swabstick

Drug Facts

Active ingredients Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin preparation: Helps to

reduce bacterial that potentially can cause skin infection

1/Pouch 2

Made in China D07310901 Rev2

Ask A Doctor Before Use If Injuries Are
  • deep or puncture wounds
  • Serious burn

Structured Label Content

Use

Antiseptic Skin Preparation

Purpose

Antispetic

Warnings

For External Use Only

Directions
  • apply product to skin as needed
  • see product box for additional directions
Do Not Use (Do not use)
  • If allergic to Iodine
  • in the eyes
Active Ingredient

Povidone-Iodine USP 10%

Other Information
  • 1% titratable iodine
  • Avoid excessive heat
  • Store at room temperature
  • For hospital or professional use only
  • Not made with natural rubber latex
Inactive Ingredients

alkyl glucoside, anhydrous citric acid, aonoxynol-10, glycerin, hydroxyethyl cellulose, potassium iodine, sodium hydroxide, water

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • infection occurs
  • redness, irritation or swelling develops
Keep Out of Reach of Children (Keep out of reach of children)

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

Dukal Povidone Iodine Gel Swabstick (Dukal Povidone-Iodine Gel Swabstick)

DUKAL™

CORPORATION

NDC 65517-0036-1

REF 899

Hold Upright and Tear Here

POVIDONE-IODINE

Gel Swabstick

Ready Gel 1X™

4" (10.2cm)

Saturated Swabstick

Drug Facts

Active ingredients Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin preparation: Helps to

reduce bacterial that potentially can cause skin infection

1/Pouch 2

Made in China D07310901 Rev2

Ask A Doctor Before Use If Injuries Are (Ask a doctor before use if injuries are)
  • deep or puncture wounds
  • Serious burn

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:18.026284 · Updated: 2026-03-14T23:10:34.945513