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

Purpose

Bactericidial - antiseptic

Description

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Medication Information

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.

Uses

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

Purpose

Bactericidial - antiseptic

Directions

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

Other Information

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

Inactive Ingredients

Ethanol, Purified Water

Description

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Section 50565-1

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

Section 51945-4

Active Ingredients

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Structured Label Content

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.

Uses

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

Purpose

Bactericidial - antiseptic

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.

Inactive Ingredients (Inactive ingredients)

Ethanol, Purified Water

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)

Active Ingredients (Active ingredients)

Iodine - 0.5 g, Potassium Iodide - 0.2 g

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

Back to search View SPL set listing Open on DailyMed ↗

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