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
Purpose

Antiseptic

Description

Povidone-Iodine USP (10%)

Medication Information

Warnings

For external use only

Do not use if allergic to iodine in the eyes

Uses

Antiseptic skin preparation

Purpose

Antiseptic

Directions

Apply locally as need

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

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 51945-4

Active Ingredient

Povidone-Iodine USP (10%)

Inactive Ingredient

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

Structured Label Content

Warnings

For external use only

Do not use if allergic to iodine in the eyes

Uses

Antiseptic skin preparation

Purpose

Antiseptic

Directions

Apply locally as need

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

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)

Active Ingredient

Povidone-Iodine USP (10%)

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