61333-205

61333-205
SPL v5
SPL
SPL Set ID 000bf57b-1805-4746-bf1c-32856241213a
Route
TOPICAL
Published
Effective Date 2019-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (0.75 g)
Inactive Ingredients
Citric Acid Monohydrate Water Sodium Phosphate Dibasic Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-18
Description

Active Ingredient: Povidone-Iodine USP (7.5%)

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 patient. Prolonged exposure to wet solution may cause skiin irritation.

Indications and Usage

Use:

Antiseptic skin preparation

Dosage and Administration

Directions:

Apply locally as needed.

Description

Active Ingredient: Povidone-Iodine USP (7.5%)

Section 50565-1

Keep out of reach of children. In case of a 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 persisits or increases

Infection occurs

Section 51727-6

Inactive Ingredient

Citric acid, purified water, Disodium hydrogen phosphate

Section 51945-4

Section 55105-1

Purpose: Antiseptic

Section 55106-9

Active Ingredient: Povidone-Iodine USP (7.5%)

Section 60561-8

Other information

  • Store at room temperature
  • 0.75% available iodine
  • Latax free
  • For hospital or professional use only

Structured Label Content

Indications and Usage (34067-9)

Use:

Antiseptic skin preparation

Dosage and Administration (34068-7)

Directions:

Apply locally as needed.

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 patient. Prolonged exposure to wet solution may cause skiin irritation.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of a 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 persisits or increases

Infection occurs

Section 51727-6 (51727-6)

Inactive Ingredient

Citric acid, purified water, Disodium hydrogen phosphate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Antiseptic

Section 55106-9 (55106-9)

Active Ingredient: Povidone-Iodine USP (7.5%)

Section 60561-8 (60561-8)

Other information

  • Store at room temperature
  • 0.75% available iodine
  • Latax 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: 2026-02-15T12:08:20.314613 · Updated: 2026-03-14T23:12:32.924893