proheal povidone iodine solution

proheal povidone iodine solution
SPL v2
SPL
SPL Set ID c80f0a7c-c083-4199-a739-c9865c5cc1ef
Route
topical
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (1 g)
Inactive Ingredients
citric acid monohydrate sodium phosphate, dibasic, anhydrous water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-22
Purpose

First aid antiseptic

Description

Povidone-iodine, 10% (1% available iodine)

Medication Information

Warnings

For external use only

Do not use

• in the eyes or apply over large areas of the body • longer than 1 week unless directed by a doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if  condition persists or gets worse

Uses

first aid to help prevent the risk of infection in: • minor cuts • scrapes • burns

Purpose

First aid antiseptic

Directions

• clean the affected area • apply a small amount of this product on the area 1 to 3 times daily • may be covered with a sterile bandage • if bandaged, let dry first

Other Information

• store at room temperature

Inactive Ingredients

citric acid, disodium hydrogen phosphate, purified water.

Description

Povidone-iodine, 10% (1% available iodine)

Section 42229-5

PREVENTS INFECTIONS ǀ BURNS AND WOUNDS

FIRST AID ANTISEPTIC

Manufactured for:

ProHeal

Surfside, FL

www.prohealproducts.com

772-776-4325

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredient

Povidone-iodine, 10% (1% available iodine)

Structured Label Content

Warnings

For external use only

Do not use

• in the eyes or apply over large areas of the body • longer than 1 week unless directed by a doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if  condition persists or gets worse

Uses

first aid to help prevent the risk of infection in: • minor cuts • scrapes • burns

Purpose

First aid antiseptic

Directions

• clean the affected area • apply a small amount of this product on the area 1 to 3 times daily • may be covered with a sterile bandage • if bandaged, let dry first

Other Information (Other information)

• store at room temperature

Inactive Ingredients (Inactive ingredients)

citric acid, disodium hydrogen phosphate, purified water.

Section 42229-5 (42229-5)

PREVENTS INFECTIONS ǀ BURNS AND WOUNDS

FIRST AID ANTISEPTIC

Manufactured for:

ProHeal

Surfside, FL

www.prohealproducts.com

772-776-4325

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Povidone-iodine, 10% (1% available iodine)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:54.163018 · Updated: 2026-03-14T23:11:53.041179