SPL v1
SPL
SPL Set ID c33becf4-a2d6-4736-9c6f-95123ed5ccde
Route
TOPICAL
Published
Effective Date 2018-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (0.2 g)
Inactive Ingredients
Water Citric Acid Monohydrate Sodium Hydroxide Glycerin Nonoxynol-10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-08-05
Description

Active Ingredient: Povidone-Iodine USP (10%)

Medication Information

Warnings and Precautions

Warnings:

Do not use

  • if allergic to iodine
  • in the eyes

For external use only

Indications and Usage

Use: Antiseptic skin preparation

Dosage and Administration

Apply product to skin 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

  • irritation or redness develops
  • condition persists for more than 72 hours
Section 51727-6

Inactive Ingredient

Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water

Section 51945-4

Section 55105-1

Purpose: Antiseptic 

Section 55106-9

Active Ingredient: Povidone-Iodine USP (10%)

Section 60561-8

Other information

  • Not made with nature rubber latex
  • Not made with DEHP
  • For single use only

Structured Label Content

Indications and Usage (34067-9)

Use: Antiseptic skin preparation

Dosage and Administration (34068-7)

Apply product to skin as need

Warnings and Precautions (34071-1)

Warnings:

Do not use

  • if allergic to iodine
  • in the eyes

For external use only

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

  • irritation or redness develops
  • condition persists for more than 72 hours
Section 51727-6 (51727-6)

Inactive Ingredient

Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, 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

  • Not made with nature rubber latex
  • Not made with DEHP
  • For single use only

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:36.938706 · Updated: 2026-03-14T22:55:12.436150