SCRUB-IN SURGICAL SCRUB BRUSH/SPONGE- povidone-iodine solution
Medline Industries, 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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Active ingredient

Povidone-Iodine solution 9%

Purpose

Surgical Hand Scrub

Uses

For cleaning hands and forearms prior to surgery

Warnings

For external use only

Do not use

in the eyes
if you are allergic to iodine or any of the other ingredients in this product

Stop use and ask a doctor if

irritation and redness develop
symptoms last for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands and forearms with water
Clean under nails with nail cleaner
Scrub with the brush, paying close attention to the nails, cuticles, and interdigital spaces
Rinse thoroughly with running water
Repeat

Other information

Avoid excessive heat above 40° C (104° F)
Protect from freezing
Latex free

Inactive ingredients

Ammonium Nonoxynol-4-Sulfate, Hydrogen Peroxide, Nonoxynol-9, Phosphoric Acid, Sodium Hydroxide, Water

Questions?

Call 1-800-MEDLINE

Package Label - Box Principal Display Panel top

Scrub-In Surgical Scrub Brush/Sponge 9% Principal Display Panel Top

NDC 53329-920-33

Scrub-In

REF DYND372453

SURGICAL SCRUB BRUSH/SPONGE

WITH NAIL CLEANER

LATEX FREE

Povidone-Iodine 9% Antiseptic Solution
Approximate Volume 18 mL
For Single Use Only

Remove to check level of contents

Reorder when brushes reach this level

QTY 30

Remove for convenient dispensing of product

Package Label - Box Principal Display Panel bottom

Scrub-In Surgical Scrub Brush/Sponge 9% Principal Display Panel Bottom

Package Label - Pouch

Scrub-In Surgical Scrub Brush/Sponge 9% Pouch Drug Facts

Package Label - Box Principal Display Panel top

Scrub-In Surgical Scrub Brush/Sponge 15% Principal Display Panel Top

NDC 53329-921-33

Scrub-In

REF DYND372053

SURGICAL SCRUB BRUSH/SPONGE

WITH NAIL CLEANER

LATEX FREE

Povidone-Iodine 15% Antiseptic Solution
Approximate Volume 15 mL
For Single Use Only

Remove to check level of contents

Reorder when brushes reach this level

QTY 30

Remove for convenient dispensing of product

Package Label - Box Principal Display Panel bottom

Scrub-In Surgical Scrub Brush/Sponge 15% Principal Display Panel Bottom

Package Label - Pouch

Scrub-In Surgical Scrub Brush/Sponge 15% Pouch Drug Facts

SCRUB-IN SURGICAL SCRUB BRUSH/SPONGE
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-920
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (IODINE)	POVIDONE-IODINE	9 mg in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM NONOXYNOL-4 SULFATE
HYDROGEN PEROXIDE
NONOXYNOL-9
PHOSPHORIC ACID
SODIUM HYDROXIDE
WATER

Packaging
#	Item Code	Package Description
1	NDC:53329-920-33	30 in 1 BOX
1	NDC:53329-920-09	18 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2012

SCRUB-IN SURGICAL SCRUB BRUSH/SPONGE
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-921
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (IODINE)	POVIDONE-IODINE	15 mg in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM NONOXYNOL-4 SULFATE
HYDROGEN PEROXIDE
NONOXYNOL-9
PHOSPHORIC ACID
SODIUM HYDROXIDE
WATER

Packaging
#	Item Code	Package Description
1	NDC:53329-921-33	30 in 1 BOX
1	NDC:53329-921-09	15 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2012

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Medline Industries, Inc.		185862984	MANUFACTURE(53329-920, 53329-921), ANALYSIS(53329-920, 53329-921)

Revised: 08/2012

Document Id: 70f806e7-0cda-4158-b9c8-3816e9925180

Set id: 70f806e7-0cda-4158-b9c8-3816e9925180

Version: 1

Effective Time: 20120831

Medline Industries, Inc.