0011 Povidone-iodine (nonsterile)

SPL v13

SPL

SPL Set ID b760668f-31be-47fa-9eee-38cb67780e21

Route

TOPICAL

Published

Effective Date 2017-05-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (10 mg)

Inactive Ingredients

Citric Acid Monohydrate Sodium Phosphate, Dibasic Nonoxynol-9 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2017-05-31 Until 2026-09-30

Description

Povidone-iodine USP 10%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-iodine USP 10%

Use

antiseptic skin preparation

Warnings

For external use only
Avoid pooling beneath patient
Avoid excessive heat. Store at room temperature

Directions

apply locally as needed

Do Not Use

• if allergic to iodine
• in the eyes

Package Label

Active Ingredient

Povidone-iodine USP 10%

Other Information

• 1% titratable iodine
• not made with natural rubber latex
• for hospital or professional use only

Inactive Ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufacturing Information

Manufactured by: Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA

www.medline.com

1-800-MEDLINE

Aplicare is a registered trademark of Medline Industries, LP.

REF: APLL30115S

Stop Use and Ask A Doctor If

• redness, irritation, swelling or pain persists or increases
• infection occurs

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Ask A Doctor Before Use If Injuries Are

• deep or puncture wounds
• serious burns

Structured Label Content

Use

antiseptic skin preparation

Purpose

Antiseptic

Warnings

For external use only
Avoid pooling beneath patient
Avoid excessive heat. Store at room temperature

Directions

apply locally as needed

Do Not Use (Do not use)

• if allergic to iodine
• in the eyes

Package Label

Active Ingredient (Active ingredient)

Povidone-iodine USP 10%

Other Information (Other information)

• 1% titratable iodine
• not made with natural rubber latex
• for hospital or professional use only

Inactive Ingredients (Inactive ingredients)

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufacturing Information

Manufactured by: Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA

www.medline.com

1-800-MEDLINE

Aplicare is a registered trademark of Medline Industries, LP.

REF: APLL30115S

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• redness, irritation, swelling or pain persists or increases
• infection occurs

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

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Ask A Doctor Before Use If Injuries Are (Ask a doctor before use if injuries are)

• deep or puncture wounds
• serious burns

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-9", "unii": "48Q180SH9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "antiseptic skin preparation", "Purpose": "Antiseptic", "Warnings": "For external use only Avoid pooling beneath patient Avoid excessive heat. Store at room temperature", "Directions": "apply locally as needed", "Do not use": "• if allergic to iodine • in the eyes", "Active ingredient": "Povidone-iodine USP 10%", "Other information": "• 1% titratable iodine • not made with natural rubber latex • for hospital or professional use only", "Inactive ingredients": "citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water", "Manufacturing Information": "Manufactured by: Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA www.medline.com 1-800-MEDLINE Aplicare is a registered trademark of Medline Industries, LP. REF: APLL30115S", "Stop use and ask a doctor if": "• redness, irritation, swelling or pain persists or increases • infection occurs", "Keep out of reach of children.": "In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.", "Ask a doctor before use if injuries are": "• deep or puncture wounds • serious burns"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:26.000630 · Updated: 2026-03-14T23:13:32.363247