73288-002

73288-002
SPL v6
SPL
SPL Set ID 6d472aef-0d95-4c21-a373-bd16bc7b63ed
Route
TOPICAL
Published
Effective Date 2019-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-19
Description

Active Ingredient: Povidone-Iodine USP (10%)

Medication Information

Warnings and Precautions

Warnings:

For external use only

Do not use if allergic to iodine or in the eyes

Indications and Usage

Use:

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

Dosage and Administration

Apply locally as need

Description

Active Ingredient: Povidone-Iodine USP (10%)

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

Section 50569-3

Stop use and ask a doctor if infection occurs or if redness, irritation, swelling, or pain persists or increases

Section 51727-6

Inactive Ingredient

Citric acid, purified water, Sodium phosphate dibasic

Section 51945-4

Section 55105-1

Purpose: Antiseptic

Section 55106-9

Active Ingredient: Povidone-Iodine USP (10%)

Structured Label Content

Indications and Usage (34067-9)

Use:

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

Dosage and Administration (34068-7)

Apply locally as need

Warnings and Precautions (34071-1)

Warnings:

For external use only

Do not use if allergic to iodine or in the eyes

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

Section 50569-3 (50569-3)

Stop use and ask a doctor if infection occurs or if redness, irritation, swelling, or pain persists or increases

Section 51727-6 (51727-6)

Inactive Ingredient

Citric acid, purified water, Sodium phosphate dibasic

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Antiseptic

Section 55106-9 (55106-9)

Active Ingredient: Povidone-Iodine USP (10%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:11.559833 · Updated: 2026-03-14T23:12:21.703136