PVP PREP- 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.

----------

Drug Facts

Active ingredient

Povidone-Iodine, 10% (equivalent to 1% available iodine)

Purpose

Antiseptic

Uses

  • Healthcare antiseptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent infection in minor cuts, scrapes, and burns

Warnings

For external use only.

Do not use

  • in the eyes
  • longer than one week unless directed by a doctor
  • on individuals who are allergic or sensitive to iodine
  • or apply over large areas of the body

Stop use and ask a doctor

  • if irritation and redness develop
  • if condition persists for more than 72 hours
  • in case of deep or puncture wounds, animal bites or serious burns.

Keep out of reach of children.

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

Directions

Clean affected area.

  • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
  • For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information

Protect from freezing. Avoid excessive heat.

Inactive ingredients

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.

Package/Label Principal Display Panel

PVP Prep Solution Label

NDC 12462-939-08

Chester Packaging

PVP Prep Solution

Topical Antiseptic

Povidone-Iodine 10%

CATALOG NO: 008208

Latex Free

8 FL OZ (236 mL)

PVP PREP 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12462-939
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12462-939-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:12462-939-5559 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3NDC:12462-939-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:12462-939-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:12462-939-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:12462-939-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:12462-939-133785 mL in 1 JUG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/201112/31/2016
Labeler - Chester Packaging, LLC (004237806)

Revised: 1/2016
Document Id: 2a435159-cb4a-28b1-e054-00144ff8d46c
Set id: 04ad8e14-f9b3-4742-9b04-5737d86ca2d6
Version: 2
Effective Time: 20160126
 
Chester Packaging, LLC