IODOPHOR SURGICAL HAND SCRUB- povidone-iodine soap
Pharmalab Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUM LABEL

Uses: Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.

Active Ingredient: Purpose

Povidone Iodine 39% (3.9% available Iodine) .......... Antiseptic

Inactive Ingredients:Lauric Diethanolamide, Ammonium Lauryl Sulfate, Glyceryl Cocoate, Panthenol, Sodium Hyrdoxide, Potassium Iodate, Water

Purpose Antiseptic

Directions:

Clean under the nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Apply a palmful (5g) of foam to hands and forearms. Scrub thoroughly for 2 minutes with a sterile scrub brush, paying particular attention to the nails, cuticles, and interdigital spaces. Rinse and repeat scrub.

Warnings: For External use only

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. Avoid contact with eyes: In case of contact, flush eyes with water

Stop use and ask a doctor if irritation or redness develops.

IodophorLabel

IODOPHOR SURGICAL HAND SCRUB
povine-iodine soap

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:14505-505
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (IODINE)	IODINE	3.9 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
LAURIC DIETHANOLAMIDE
AMMONIUM LAURYL SULFATE
GLYCERYL COCOATE
PANTHENOL
SODIUM HYDROXIDE
POTASSIUM IODATE
WATER

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14505-505-99	200000 g in 1 DRUM

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	06/11/2010	08/01/2012

Labeler - Pharmalab Enterprises Inc. (174401088)

Revised: 2/2014

Document Id: 2236c628-acd9-480f-8eba-f3fb8ae37420

Set id: 42f76be3-4034-496f-91ab-4ec01fb4e48b

Version: 6

Effective Time: 20140205

Pharmalab Enterprises Inc.