81526-002

81526-002
SPL v5
SPL
SPL Set ID af7840c0-239e-4ff6-8d27-614e7d71ca99
Route
TOPICAL
Published
Effective Date 2021-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-21
Description

Povidone-Iodine USP (10%)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine USP (10%)

Uses

Antiseptic skin preparation

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 51945-4

Warnings

For external use only

Do not use if allergic to iodine in the eyes

Directions

Apply locally as need

Active Ingredient

Povidone-Iodine USP (10%)

Other Information
  • not made with natural rubber latex
  • for hospital or professional use only
Inactive Ingredient

Glycerin, Propylene Glycol, PEG 1450, Sodium Hydrogen Phosphate, Citric Acid, Water

Structured Label Content

Uses

Antiseptic skin preparation

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 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only

Do not use if allergic to iodine in the eyes

Directions

Apply locally as need

Active Ingredient

Povidone-Iodine USP (10%)

Other Information (Other information)
  • not made with natural rubber latex
  • for hospital or professional use only
Inactive Ingredient

Glycerin, Propylene Glycol, PEG 1450, Sodium Hydrogen Phosphate, Citric Acid, Water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.979949 · Updated: 2026-03-14T23:07:05.651363