FDA.reportPublic FDA data

PROHEAL POVIDONE IODINE PREP PADS

Manufacturer
Click Industries LLC
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:28:34

Label at a glance#

ProductPROHEAL POVIDONE IODINE PREP PADS
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and 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

Dosage and administration

• 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 

Storage and handling

• Store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

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 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 

Other information

STORAGE AND HANDLING SECTION

• Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid Monohydrate, Sodium Phosphate Dibasic, Water

SPL UNCLASSIFIED SECTION

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROHEAL POVIDONE IODINE PREP PADSPROHEAL POVIDONE IODINE PREP PADS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300277povidone-iodine gel 10 % Medicated PadPSN1
1300277povidone-iodine 0.1 MG/MG Medicated PadSCD1
1300277povidone-iodine 10 % (titratable iodine 1 % ) Gel SwabstickSY1
1300277povidone-iodine 10 % Gel SwabstickSY1
1300277povidone-iodine 10 % SwabstickSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86173-002-12PROHEAL POVIDONE IODINE PREP PADS1 in 1 PACKETCLOTH11
86173-002-12PROHEAL POVIDONE IODINE PREP PADS120 in 1 BOXCLOTH1201
86173-002-30PROHEAL POVIDONE IODINE PREP PADS1 in 1 PACKETCLOTH11
86173-002-30PROHEAL POVIDONE IODINE PREP PADS30 in 1 BOXCLOTH301
86173-002-60PROHEAL POVIDONE IODINE PREP PADS1 in 1 PACKETCLOTH11
86173-002-60PROHEAL POVIDONE IODINE PREP PADS60 in 1 BOXCLOTH601

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86173-00286173-002-30, 86173-002-60, 86173-002-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEE1W4N241FOIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROHEAL POVIDONE IODINE PREP PADSPOVIDONE-IODINEClick Industries LLC53733b6c-fa62-43e0-bfcc-3d23b5e1a95a2025-10-23WarningsExact identifier
ndc (package): 86173-002-12
ndc (package): 86173-002-60
ndc (package): 86173-002-30
ndc (product): 86173-002
ndc11 (package): 86173000212
ndc11 (package): 86173000260
ndc11 (package): 86173000230
spl id: 50364a26-5432-47a6-a648-72b14c0749dd
spl set id: 53733b6c-fa62-43e0-bfcc-3d23b5e1a95a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.