Povidone-iodine Prep Pad

SPL v5

SPL

SPL Set ID ad5abf95-d332-4afd-a344-9696edd43d63

Route

TOPICAL

Published

Effective Date 2013-08-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (9.43 g)

Inactive Ingredients

Water Citric Acid Monohydrate Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-01-15

Description

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Indications and Usage

First aid to help prevent infection in minor cuts, scrapes, and burns

Purpose

Antiseptic

Medication Information

Indications and Usage

First aid to help prevent infection in minor cuts, scrapes, and burns

Purpose

Antiseptic

Description

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use

﹒in the eyes or apply over large areas of the body.

﹒on individuals who are allergic or sensitive to iodine.

Stop use

If irritation, redness or other symptoms develop.

Ask a doctor

If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

Drug Facts

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use

﹒in the eyes or apply over large areas of the body.

﹒on individuals who are allergic or sensitive to iodine.

Stop use

If irritation, redness or other symptoms develop.

Ask a doctor

If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

CAUTION: Keep out of reach of children.

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

Directions

Apply product on the area 1-3 times daily and discard.

Other information: Store at room temperature.

Inactive ingredients

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

Directions

Apply product on the area 1-3 times daily and discard.

Active Ingredient

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Inactive Ingredient

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

Indications and Usage Section

First aid to help prevent infection in minor cuts, scrapes, and burns

Caution: Keep Out of Reach of Children

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

Structured Label Content

Purpose

Antiseptic

Warnings (WARNINGS)

For external use only. Flammable, keep away from fire or flame.

Do not use

﹒in the eyes or apply over large areas of the body.

﹒on individuals who are allergic or sensitive to iodine.

Stop use

If irritation, redness or other symptoms develop.

Ask a doctor

If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

Drug Facts (DRUG FACTS)

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use

﹒in the eyes or apply over large areas of the body.

﹒on individuals who are allergic or sensitive to iodine.

Stop use

If irritation, redness or other symptoms develop.

Ask a doctor

If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

CAUTION: Keep out of reach of children.

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

Directions

Apply product on the area 1-3 times daily and discard.

Other information: Store at room temperature.

Inactive ingredients

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

Directions

Apply product on the area 1-3 times daily and discard.

Active Ingredient (Active ingredient)

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Inactive Ingredient (INACTIVE INGREDIENT)

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

Indications and Usage Section (Indications and usage section)

First aid to help prevent infection in minor cuts, scrapes, and burns

Caution: Keep Out of Reach of Children (CAUTION: Keep out of reach of children)

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

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "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": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "9.43", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Purpose": "Antiseptic", "WARNINGS": "For external use only. Flammable, keep away from fire or flame. Do not use ﹒in the eyes or apply over large areas of the body. ﹒on individuals who are allergic or sensitive to iodine. Stop use If irritation, redness or other symptoms develop. Ask a doctor If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.", "DRUG FACTS": "Active ingredient Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine) Purpose Antiseptic Use First aid to help prevent infection in minor cuts, scrapes, and burns Warnings For external use only. Flammable, keep away from fire or flame. Do not use ﹒in the eyes or apply over large areas of the body. ﹒on individuals who are allergic or sensitive to iodine. Stop use If irritation, redness or other symptoms develop. Ask a doctor If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns. CAUTION: Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. Directions Apply product on the area 1-3 times daily and discard. Other information: Store at room temperature. Inactive ingredients ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide", "Directions": "Apply product on the area 1-3 times daily and discard.", "Active ingredient": "Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)", "INACTIVE INGREDIENT": "ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide", "Indications and usage section": "First aid to help prevent infection in minor cuts, scrapes, and burns", "CAUTION: Keep out of reach of children": "If swallowed, get medical help or contact Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:38.811517 · Updated: 2026-03-14T22:55:16.609561