Povidone iodine topical solution paint liquid

Spl unclassified section

Drug Facts

Active ingredient

Povidone-Iodine, USP10%

(1.0%available iodine)

Purpose

patient preoperative prep

Use

prepping intact skin and mucous membranes prior to sugery

Warnings

for external use only

avoid use on persons allergic to iodine

Stop using this product and ask a doctor if

  • skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Keep out of reach of children.

if swallowed, get medical helpor contact a Poison Control Center right away

Directions

Patient preoperative prep

  • apply solution to operative site following povidone iodine scrub application
  • using a circular motion, start at incision site and move outward
  • remove all soiled underdrapes
  • do no allow solution to pool

Other information

  • store at room temperature
  • avoid excessive heat (above 104 degrees F/40 degrees C)
  • protect from freezing
  • latex free

Inactive ingredients

Purified Water, nonylphenol ethoxylate, glycerol

Ingredients and appearance - Product information

Povidone iodine topical solution paint liquid- Povidone iodine 10%

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 34645-1040
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Povidone-iodine ( UNII: 85H0HZU99M)( Iodine - UNII: 9679TC07X4 ) 100 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Nonoxynol-9 ( UNII: 48Q180SH9T)
Glycerin ( UNII: PDC6A3C0OX)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 34645-1040-1 3785mL in 1 BOTTLE 2015/03/31
2 NDC: 34645-1040-2 59mL in 1 BOTTLE 2015/03/31

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part333A USA 2015/03/31

Labeler - Jiangsu Province Jianerkang Medical Dressing Co., Ltd.( 530968767)

Establishment

Name ID/FEI Business Operations
Jiangsu Province Jianerkang Medical Dressing Co., Ltd. 530968767 manufacture( 34645-1040)

Package labeling