61333-204

61333-204
SPL v5
SPL
SPL Set ID 2610fde4-4572-4d15-a970-f6d3beb734fe
Route
TOPICAL
Published
Effective Date 2019-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1 g)
Inactive Ingredients
Water Citric Acid Monohydrate Sodium Phosphate Dibasic Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-01
Description

Active Ingredient: Povidone-Iodine USP (10%)

Medication Information

Warnings and Precautions

Warnings:

For external use only

Do not *use or apply to the eyes *to individuals who are allergic or sensitive to iodine, *over large area of the body, *as first aid antiseptic longer than a week unless directed by a doctor 

Indications and Usage

Use:

Health care antiseptic for prepapration of skin prior to surgery.

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

Dosage and Administration

For preparation of the skin prior surgery: clean the affacted area, remove swabstick, apply to the operative site prior to surgery

For use as first aid antiseptic: clean the affacted area, apply a small anount of the product to the area 1-3 times daily. Maybe covered with a sterile bandage. If bandaged, let dry first.

Description

Active Ingredient: Povidone-Iodine USP (10%)

Label

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or consult a poison control center immediately

Section 50569-3

Discontinue use if irritation and redness develop. Consult a doctor iin case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if infection occurs or if condition persists or increases

Section 51727-6

Inactive Ingredient

Citric acid, purified water, Sodium phosphate dibasic

Section 55105-1

Purpose: Antiseptic

Section 55106-9

Active Ingredient: Povidone-Iodine USP (10%)

Section 60561-8

Other information

  • Store at room temperature

Structured Label Content

Label (label)

Indications and Usage (34067-9)

Use:

Health care antiseptic for prepapration of skin prior to surgery.

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

Dosage and Administration (34068-7)

For preparation of the skin prior surgery: clean the affacted area, remove swabstick, apply to the operative site prior to surgery

For use as first aid antiseptic: clean the affacted area, apply a small anount of the product to the area 1-3 times daily. Maybe covered with a sterile bandage. If bandaged, let dry first.

Warnings and Precautions (34071-1)

Warnings:

For external use only

Do not *use or apply to the eyes *to individuals who are allergic or sensitive to iodine, *over large area of the body, *as first aid antiseptic longer than a week unless directed by a doctor 

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or consult a poison control center immediately

Section 50569-3 (50569-3)

Discontinue use if irritation and redness develop. Consult a doctor iin case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if infection occurs or if condition persists or increases

Section 51727-6 (51727-6)

Inactive Ingredient

Citric acid, purified water, Sodium phosphate dibasic

Section 55105-1 (55105-1)

Purpose: Antiseptic

Section 55106-9 (55106-9)

Active Ingredient: Povidone-Iodine USP (10%)

Section 60561-8 (60561-8)

Other information

  • Store at room temperature

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:20.320668 · Updated: 2026-03-14T23:12:32.924893