Povidone-iodine Prep Solution

SPL v7

SPL

SPL Set ID f3e0af11-39b6-44a0-8f84-a4b36631e8f0

Route

TOPICAL

Published

Effective Date 2019-02-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (100 mg)

Inactive Ingredients

Water Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-03-01

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

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 • for hospital or professional use only

Package Labeling:

Inactive Ingredients

Purified water, Glycerin, Nonyl nonoxynol-10

Ask A Doctor Before Use

if injuries are • deep or puncture wounds • serious burns

Stop Use and Ask A Doctor If

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

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.

Keep Out of Reach of Children.

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

Structured Label Content

Use

Antiseptic skin preparation

Purpose

Antiseptic

Warnings

For external use only

Directions

Apply locally as needed

Do Not Use (Do not use)

• if allergic to iodine • in the eyes

Active Ingredient (Active ingredient)

Povidone-iodine USP 10%

Other Information (Other information)

• 1% titratable iodine • for hospital or professional use only

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Purified water, Glycerin, Nonyl nonoxynol-10

Ask A Doctor Before Use (Ask a doctor before use)

if injuries are • deep or puncture wounds • serious burns

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

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

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.

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.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Antiseptic skin preparation", "Purpose": "Antiseptic", "Warnings": "For external use only", "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 • for hospital or professional use only", "Inactive ingredients": "Purified water, Glycerin, Nonyl nonoxynol-10", "Ask a doctor before use": "if injuries are • deep or puncture wounds • serious burns", "Stop use and ask a doctor if": "• infection occurs • redness, irritation, swelling or pain persists or increases Avoid pooling beneath patient Avoid excessive heat. Store at room temperature.", "Keep out of reach of children.": "In case of accidental ingestion, seek professional assistance or consult a poison control center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:28.768568 · Updated: 2026-03-14T23:12:59.392851