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

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

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
• 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

Structured Label Content

Use

antiseptic skin preparation

Purpose

Antiseptic

Warnings

For external use only
Avoid pooling beneath patient

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
• for single use only

Storage Information

Avoid excessive heat.Store at room temperature.

Inactive Ingredients (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 (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

Back to search View SPL set listing Open on DailyMed ↗

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