5101 aplicare povidone-iodine triples

SPL v6

SPL

SPL Set ID c674b28c-2c8d-43a8-9d6c-ab710e404089

Route

topical

Published

Effective Date 2017-05-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

iodine (10 mg)

Inactive Ingredients

sodium phosphate, dibasic citric acid monohydrate sodium hydroxide nonoxynol-9 water

Identifiers & Packaging

Marketing Status

otc monograph not final completed Since 2017-05-31 Until 2025-11-30

Purpose

Antiseptic

Description

Povidone-iodine USP 10%

Medication Information

Warnings

For external use only
Avoid pooling beneath patient

Purpose

Antiseptic

Directions

apply locally as needed

Other Information

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

Inactive Ingredients

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

Description

Povidone-iodine USP 10%

Use

antiseptic skin preparation

Do Not Use

• if allergic to iodine
• in the eyes

Package Label

Active Ingredient

Povidone-iodine USP 10%

Storage Information

Avoid excessive heat.Store at room temperature.

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

1-800-633-5463

REF: APLS3111

0117

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

Warnings

For external use only
Avoid pooling beneath patient

Purpose

Antiseptic

Directions

apply locally as needed

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Use

antiseptic skin preparation

Do Not Use (Do not use)

• if allergic to iodine
• in the eyes

Package Label

Active Ingredient (Active ingredient)

Povidone-iodine USP 10%

Storage Information

Avoid excessive heat.Store at room temperature.

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

1-800-633-5463

REF: APLS3111

0117

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": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-9", "unii": "48Q180SH9T", "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", "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 • for single use only", "Storage Information": "Avoid excessive heat. Store at room temperature.", "Inactive ingredients": "citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water", "Manufacturing Information": "Manufactured by: Aplicare Products, LLC 550 Research Parkway, Meriden, CT 06450 USA Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA with domestic and foreign materials 1-800-633-5463 REF: APLS3111 0117", "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

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Source: dailymed · Ingested: 2026-02-15T12:01:06.881696 · Updated: 2026-03-14T23:01:15.754566