Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID a115cb42-a286-46ab-abb9-526bb3c2498e
Route
TOPICAL
Published
Effective Date 2009-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (0.1 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-01-01
Description

Cat.40000-020      NDC 34645-4002-1     Qty. 1ea Povidone-Iodine Prep Pad Antiseptic/Germicide, Medium*For Single Use Only Saturated with a 10% povidone-iodine solution equivalent to 1% titratable iodine For External Use Only Distributed by: Cardinal Health Dublin, OH 43017 USA Made in China

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Directions

Clean the affected area

Apply product on the area 1-3 times daily and discard

May be covered with a sterile bandage when dry

Description

Cat.40000-020      NDC 34645-4002-1     Qty. 1ea Povidone-Iodine Prep Pad Antiseptic/Germicide, Medium*For Single Use Only Saturated with a 10% povidone-iodine solution equivalent to 1% titratable iodine For External Use Only Distributed by: Cardinal Health Dublin, OH 43017 USA Made in China

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and consult a doctor

if the condition persists or gets worse

for use longer than 1 week

Section 50567-7

Use

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

Section 50569-3

Ask doctor

in case of deep or puncture wounds, animal bites, serious burns.

Section 50570-1

Do not * use in the eyes * apply over large areas of the body

* use on individuals who are allergic or sensitive to iodine

Section 51727-6

Inactive ingredients

ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

Section 51945-4

Cat.40000-020      NDC 34645-4002-1     Qty. 1ea

Povidone-Iodine Prep Pad

Antiseptic/Germicide, Medium*For Single Use Only

Saturated with a 10% povidone-iodine solution

equivalent to 1% titratable iodine

For External Use Only

Distributed by:

Cardinal Health

Dublin, OH 43017 USA

Made in China

Section 55105-1

Purpose

First Aid

Antiseptic

Section 55106-9

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

Structured Label Content

Indications and Usage (34067-9)

Directions

Clean the affected area

Apply product on the area 1-3 times daily and discard

May be covered with a sterile bandage when dry

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and consult a doctor

if the condition persists or gets worse

for use longer than 1 week

Section 50567-7 (50567-7)

Use

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

Section 50569-3 (50569-3)

Ask doctor

in case of deep or puncture wounds, animal bites, serious burns.

Section 50570-1 (50570-1)

Do not * use in the eyes * apply over large areas of the body

* use on individuals who are allergic or sensitive to iodine

Section 51727-6 (51727-6)

Inactive ingredients

ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

Section 51945-4 (51945-4)

Cat.40000-020      NDC 34645-4002-1     Qty. 1ea

Povidone-Iodine Prep Pad

Antiseptic/Germicide, Medium*For Single Use Only

Saturated with a 10% povidone-iodine solution

equivalent to 1% titratable iodine

For External Use Only

Distributed by:

Cardinal Health

Dublin, OH 43017 USA

Made in China

Section 55105-1 (55105-1)

Purpose

First Aid

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:01.657107 · Updated: 2026-03-14T22:52:20.145878