Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID dd1996bf-d7b4-4737-97fa-d98dda09e5c6

Route

TOPICAL

Published

Effective Date 2015-11-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Iodine (10 mL) Iodide Ion (0.5 g)

Inactive Ingredients

Ethanol, 2-(bis(2-methylpropyl)phenoxy)- Water

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 1999-10-20

Description

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Purpose

Bactericidial - antiseptic

Medication Information

Purpose

Bactericidial - antiseptic

Description

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Uses

For inflammatory and infectious diseases of skin, cuts, minor injuries, wounds, myositis, neuraldia; for disinfection of the operational field.

Section 50565-1

Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control center immediately.

Section 51945-4

Warnings

For external use only.

Avoid contact with eyes. If contact occurs, rinse eyes throughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Directions

Apply to affected areas as needed or as directed by physician.

Other Information

Keep in a dark place at temperature below 25 ^oC.

Active Ingredients

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Inactive Ingredients

Ethanol, Purified Water

Structured Label Content

Uses

For inflammatory and infectious diseases of skin, cuts, minor injuries, wounds, myositis, neuraldia; for disinfection of the operational field.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control center immediately.

Section 51945-4 (51945-4)

Purpose

Bactericidial - antiseptic

Warnings

For external use only.

Avoid contact with eyes. If contact occurs, rinse eyes throughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Directions

Apply to affected areas as needed or as directed by physician.

Other Information (Other information)

Keep in a dark place at temperature below 25 ^oC.

Active Ingredients (Active ingredients)

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Inactive Ingredients (Inactive ingredients)

Ethanol, Purified Water

Advanced Ingredient Data

[{"name": "ETHANOL, 2-(BIS(2-METHYLPROPYL)PHENOXY)-", "unii": "AUK0O5KW1Y", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "10", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "10", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "IODIDE ION", "unii": "09G4I6V86Q", "classCode": "ACTIM", "strengthNumerator": "0.2", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For inflammatory and infectious diseases of skin, cuts, minor injuries, wounds, myositis, neuraldia; for disinfection of the operational field.", "50565-1": "Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control center immediately.", "Purpose": "Bactericidial - antiseptic", "Warnings": "For external use only. Avoid contact with eyes. If contact occurs, rinse eyes throughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.", "Directions": "Apply to affected areas as needed or as directed by physician.", "Other information": "Keep in a dark place at temperature below 25 o C.", "Active ingredients": "Iodine - 0.5 g, Potassium Iodide - 0.2 g", "Inactive ingredients": "Ethanol, Purified Water"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:01.433240 · Updated: 2026-03-14T22:54:11.557814