PVP SCRUB- povidone-iodine solution
Chester Packaging, LLC

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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Drug Facts

Active ingredient

Povidone-Iodine, 7.5% (equivalent to 0.75% available iodine)

Purpose

Antiseptic

Uses

For preparation of the skin prior to surgery
helps to reduce bacteria that potentially can cause skin infection
significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only.

Do not use

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

When using this product

prolonged exposure to wet solution may cause irritation, or rarely, severe skin reactions
in pre-operative prepping, avoid "pooling" beneath the patient

Stop use and ask a doctor

if irritation and redness develop
if condition persists 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

Surgical Hand Scrub:

Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge.
Wet hands and forearms
Apply 5 milliliters (teaspoonful) or palmful to hands and forearms
Scrub thoroughly for about 5 minutes paying particular attention to the nails, cuticles, and interdigital spaces
Use a sterile scrub brush, if desired
Rinse and repeat scrub.

Patient Pre-operative Skin Preparation:

Prior to surgery, wet skin with water
Apply scrub to the operative site
Scrub thoroughly for about 5 minutes
Rinse using sterile gauze or towel, or remove with 70 percent alcohol
Follow with application of Chester Prep Solution and allow to dry.

Other Information

Protect from freezing. Avoid excessive heat.

Inactive ingredients

Citric Acid, Cocamide DEA, Disodium Phosphate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water.

Package/Label Principal Display Panel

NDC 12462-938-08

Chester Packaging

PVP Scrub Solution

Antiseptic

Povidone-Iodine 7.5%

Sudsing Skin Cleanser

CATALOG NO: 008308

Latex Free

8 FL OZ (236 mL)

PVP SCRUB
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12462-938
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.75 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:12462-938-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:12462-938-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:12462-938-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:12462-938-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:12462-938-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:12462-938-13	3785 mL in 1 JUG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/01/2011	12/31/2016

Labeler - Chester Packaging, LLC (004237806)

Revised: 1/2016

Document Id: 2a431b1f-e60c-214d-e054-00144ff8d46c

Set id: 825f6f3d-3b29-4fad-8bde-79b19ccf2370

Version: 2

Effective Time: 20160126

Chester Packaging, LLC