PROHEAL POVIDONE IODINE- povidone-iodine solution

PROHEAL POVIDONE IODINE by

Drug Labeling and Warnings

PROHEAL POVIDONE IODINE by is a Otc medication manufactured, distributed, or labeled by Click Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use:

Antiseptic skin preparation.

Warnings:

1. Do not use if allergic to iodine.

2. For external use only.

3. Ask a doctor before use if injuries are
deep or puncture wounds  serious burns

4. Stop use and ask a doctor if
 redness, irritation, swelling or pain persists or increases
 infection occurs

5. Do not use in eyes.

6. Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

7. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

Apply locally as need.

Other information:

1% available iodine
 latex free
 for hospital or professional use only

Inactive ingredients:

Disodium hydrogen phosphate, Citric acid, Purified water.

SPL UNCLASSIFIED SECTION

PREVENTS INFECTIONS ǀ BURNS AND WOUNDS

FIRST AID ANTISEPTIC

Manufactured for:
ProHeal
Surfside, FL
www.prohealproducts.com
772-776-4325

Packaging

INGREDIENTS AND APPEARANCE

PROHEAL POVIDONE IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86173-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86173-004-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/22/2025
2	NDC: 86173-004-48	48 in 1 CASE	10/22/2025
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 86173-004-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/22/2025
4	NDC: 86173-004-21	12 in 1 CASE	10/22/2025
4		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	10/22/2025

Labeler - Click Industries LLC (117033580)