Proheal Povidone Iodine Prep Pads 

Proheal Povidone Iodine Prep Pads 
SPL v1
SPL
SPL Set ID 53733b6c-fa62-43e0-bfcc-3d23b5e1a95a
Route
TOPICAL
Published
Effective Date 2025-12-19
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, Dodecahydrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-19

Description

Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Uses

• health care antiseptic for preparation of the skin prior to surgery • first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns

Section 42229-5

FIRST AID ANTISEPTIC

Non Sterile

Paraben Free

INDIVIDUALLY WRAPPED 

SINGLE USE ONLY 

How to use:

Tear Open Packet 

Use tear notch for easy opening.

Remove Pad 

Hold away from surfaces.

Apply to Area 

Wipe skin thoroughly.  Allow to air dry.

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. 

Warnings

For external use only

Do not use • in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic for more than 1 week unless directed by a doctor

Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious wounds

Stop use and ask a doctor if • condition worsens or persists for more than 72 hours • irritation and redness develops 

Packaging

Directions

• for preparation of the skin prior to surgery, clean the affected area, remove the pad, apply to the operative site prior to surgery • for use as a first aid antiseptic, clean the affected area, apply a small amount of this product on the area 1-3 times daily • may be covered with a sterile bandage • if bandaged, let dry first 

Drug Facts

Active Ingredient

Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Other Information

• Store at room temperature

Inactive Ingredients

Citric Acid Monohydrate, Sodium Phosphate Dibasic, Water


Structured Label Content

Uses

• health care antiseptic for preparation of the skin prior to surgery • first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns

Section 42229-5 (42229-5)

FIRST AID ANTISEPTIC

Non Sterile

Paraben Free

INDIVIDUALLY WRAPPED 

SINGLE USE ONLY 

How to use:

Tear Open Packet 

Use tear notch for easy opening.

Remove Pad 

Hold away from surfaces.

Apply to Area 

Wipe skin thoroughly.  Allow to air dry.

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. 

Purpose

Antiseptic

Warnings

For external use only

Do not use • in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic for more than 1 week unless directed by a doctor

Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious wounds

Stop use and ask a doctor if • condition worsens or persists for more than 72 hours • irritation and redness develops 

Packaging

Directions

• for preparation of the skin prior to surgery, clean the affected area, remove the pad, apply to the operative site prior to surgery • for use as a first aid antiseptic, clean the affected area, apply a small amount of this product on the area 1-3 times daily • may be covered with a sterile bandage • if bandaged, let dry first 

Drug Facts

Active Ingredient (Active ingredient)

Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Other Information (Other information)

• Store at room temperature

Inactive Ingredients (Inactive ingredients)

Citric Acid Monohydrate, Sodium Phosphate Dibasic, Water


Advanced Ingredient Data


Raw Label Data

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