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

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.

Active Ingredient

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

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

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

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

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

Advanced Ingredient Data

[{"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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", "34071-1": "Warnings For external use only.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.", "50566-9": "Stop use and consult a doctor if the condition persists or gets worse for use longer than 1 week", "50567-7": "Use First aid to help prevent infection in minor cuts, scrapes, and burns", "50569-3": "Ask docto r in case of deep or puncture wounds, animal bites, serious burns.", "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", "51727-6": "Inactive ingredients ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide", "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", "55105-1": "Purpose First Aid Antiseptic", "55106-9": "Active ingredient Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)"}

Additional Information

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