Swan 088.000/088aa

SPL v2

SPL

SPL Set ID 857f13fe-51c9-4e5b-b5e2-a981dedabf71

Route

TOPICAL

Published

Effective Date 2025-06-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (20 mg)

Inactive Ingredients

Alcohol Water Sodium Iodide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-08-07

Description

Iodine tincture U.S.P. 100% (2% Iodine)

Purpose

First aid antiseptic

Medication Information

Purpose

First aid antiseptic

Description

Iodine tincture U.S.P. 100% (2% Iodine)

Use

First aid to help prevent skin infection in

minor cuts
scrapes
burns

Warnings

For external use only

Directions

clean the affected area
apply a small amount on the area 1 to 3 times daily
may be covered with a sterile bandage
if bandaged, let dry first

Adverse Reaction

Vi-Jon One Swan Drive, Smyrna, TN 37167

Active Ingredient

Iodine tincture U.S.P. 100%

(2% Iodine)

Other Information

product will stain skin and clothing

Inactive Ingredients

alcohol (47% v/v), purified water, sodium iodide

Principal Display Panel

FOR EXTERNAL USE ONLY

Swan _®

Iodine Tincture U.S.P.

First Aid Antiseptic

CAUTION POISON

1 FL OZ (30 mL)

When Using This Product

do not use in eyes or apply over large areas of the body
do not use longer than 1 week unless directed by a doctor

Ask A Doctor If You Have

deep or puncture wounds, animal bites or serious burns

Stop Use and Ask A Doctor If

condition persists or gets worse

Keep Out of Reach of Children.

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

Structured Label Content

Use

First aid to help prevent skin infection in

minor cuts
scrapes
burns

Purpose

First aid antiseptic

Warnings

For external use only

Directions

clean the affected area
apply a small amount on the area 1 to 3 times daily
may be covered with a sterile bandage
if bandaged, let dry first

Adverse Reaction (ADVERSE REACTION)

Vi-Jon One Swan Drive, Smyrna, TN 37167

Active Ingredient

Iodine tincture U.S.P. 100%

(2% Iodine)

Other Information (Other information)

product will stain skin and clothing

Inactive Ingredients (Inactive ingredients)

alcohol (47% v/v), purified water, sodium iodide

Principal Display Panel (Principal display panel)

FOR EXTERNAL USE ONLY

Swan _®

Iodine Tincture U.S.P.

First Aid Antiseptic

CAUTION POISON

1 FL OZ (30 mL)

When Using This Product (When using this product)

do not use in eyes or apply over large areas of the body
do not use longer than 1 week unless directed by a doctor

Ask A Doctor If You Have (Ask a doctor if you have)

deep or puncture wounds, animal bites or serious burns

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

condition persists or gets worse

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM IODIDE", "unii": "F5WR8N145C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "First aid to help prevent skin infection in minor cuts scrapes burns", "Purpose": "First aid antiseptic", "Warnings": "For external use only", "Directions": "clean the affected area apply a small amount on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first", "ADVERSE REACTION": "Vi-Jon One Swan Drive, Smyrna, TN 37167", "Active Ingredient": "Iodine tincture U.S.P. 100% (2% Iodine)", "Other information": "product will stain skin and clothing", "Inactive ingredients": "alcohol (47% v/v), purified water, sodium iodide", "Principal display panel": "FOR EXTERNAL USE ONLY Swan ® Iodine Tincture U.S.P. First Aid Antiseptic CAUTION POISON 1 FL OZ (30 mL)", "When using this product": "do not use in eyes or apply over large areas of the body do not use longer than 1 week unless directed by a doctor", "Ask a doctor if you have": "deep or puncture wounds, animal bites or serious burns", "Stop use and ask a doctor if": "condition persists or gets worse", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:22.852178 · Updated: 2026-03-14T23:09:09.169888