61333-202

61333-202
SPL v6
SPL
SPL Set ID 7d4a92be-0601-4256-bc5b-bc1b07d97bb7
Route
TOPICAL
Published
Effective Date 2014-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1.18 g)
Inactive Ingredients
Citric Acid Monohydrate Water Sodium Phosphate, Dibasic

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-22
Description

Active Ingredient: Povidone-Iodine USP (10%)

Medication Information

Warnings and Precautions

Warnings:

Do not use if allergic to iodine

For external use only

Do not use in eyes

Avoid "pooling" beneath patients. Prolonged exposure to wet solution may cause skin irritation

Indications and Usage

Use: Antiseptic skin preparation

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 or puncture wounds
  • serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling, or pain persists or increases
  • infection occurs
Section 51727-6

Inactive Ingredient

Disodium hydrogen phosphate, citric acid, water

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: Antiseptic skin preparation

Dosage and Administration (34068-7)

Apply locally as need

Warnings and Precautions (34071-1)

Warnings:

Do not use if allergic to iodine

For external use only

Do not use in eyes

Avoid "pooling" beneath patients. Prolonged exposure to wet solution may cause skin irritation

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 or puncture wounds
  • serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling, or pain persists or increases
  • infection occurs
Section 51727-6 (51727-6)

Inactive Ingredient

Disodium hydrogen phosphate, citric acid, water

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: 2026-02-15T12:08:20.377214 · Updated: 2026-03-14T23:12:32.924893