61333-203

61333-203
SPL v7
SPL
SPL Set ID e561332d-e419-43db-a68e-0c0d49b01c9a
Route
TOPICAL
Published
Effective Date 2015-10-15
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-10-15
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

Ask a doctor before use if injuries are deep wounds, puncture wounds or serious burns

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%)

Section 60561-8

Other information

  • 1% available iodine
  • latex free
  • for hospital or professional use only

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)

Ask a doctor before use if injuries are deep wounds, puncture wounds or serious burns

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%)

Section 60561-8 (60561-8)

Other information

  • 1% available iodine
  • latex free
  • for hospital or professional use only

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:20.406919 · Updated: 2026-03-14T23:12:34.529887