Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID cb5c846e-0234-4ffa-8c12-40ea78ccaf1e

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.40000-040 NDC 34645-4000-2 Qty. 1ea Povidone-Iodine Swab Stick Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat 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

Section 44425-7

Other information

Store at room temperature: 15^o - 30^o C (59^o-86^o F)

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Discontinue use

If irritation and redness develop. If condition persists for more than 71 hours, consult a doctor.

Section 50567-7

Uses

Health-care antiseptic for preparation of the skin prior to surgery

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

Section 50569-3

Consult a doctor in case of

* deep or puncture wounds * animal bites * serious burns.

Section 50570-1

Do not * use in the eyes * use on individuals who are allergic or sensitive to iodine

* apply over large areas of the body * use as a first aid antiseptic longer than 1 week unless directed by a doctor.

Section 51727-6

Inactive ingredients

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

Section 51945-4

Cat.40000-040 NDC 34645-4000-2 Qty. 1ea

Povidone-Iodine Swab Stick

Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat

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

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 44425-7 (44425-7)

Other information

Store at room temperature: 15^o - 30^o C (59^o-86^o F)

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Discontinue use

If irritation and redness develop. If condition persists for more than 71 hours, consult a doctor.

Section 50567-7 (50567-7)

Uses

Health-care antiseptic for preparation of the skin prior to surgery

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

Section 50569-3 (50569-3)

Consult a doctor in case of

* deep or puncture wounds * animal bites * serious burns.

Section 50570-1 (50570-1)

Do not * use in the eyes * use on individuals who are allergic or sensitive to iodine

* apply over large areas of the body * use as a first aid antiseptic longer than 1 week unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Cat.40000-040 NDC 34645-4000-2 Qty. 1ea

Povidone-Iodine Swab Stick

Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat

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

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

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.", "44425-7": "Other information Store at room temperature: 15 o - 30 o C (59 o -86 o F)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Discontinue u se If irritation and redness develop. If condition persists for more than 71 hours, consult a doctor.", "50567-7": "Uses Health-care antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns.", "50569-3": "Consult a doctor in case of * deep or puncture wounds * animal bites * serious burns.", "50570-1": "Do not * use in the eyes * use on individuals who are allergic or sensitive to iodine * apply over large areas of the body * use as a first aid antiseptic longer than 1 week unless directed by a doctor.", "51727-6": "Inactive ingredients aitric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide", "51945-4": "Cat.40000-040 NDC 34645-4000-2 Qty. 1ea Povidone-Iodine Swab Stick Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat 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 Antiseptic", "55106-9": "Active ingredient Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:01.661541 · Updated: 2026-03-14T22:52:20.145878