ECOLAB- povidone iodine  solution 
Ecolab 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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Drug Facts

Active ingredient

Povidone Iodine, 7.5%

Purposes

Surgical hand scrub

Antiseptic handwash

Uses

  • surgical hand scrub: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
  • antiseptic hand wash: for handwashing to help reduce bacteria on the skin

Warnings

For external use only

Do not use

  • in eyes

When using this product

  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop

Stop use and ask a doctor if

  • skin irritation and redness occurs for more than 72 hours.

Keep out of reach of children.  If swallowed, get medical help or contact Poison Control Center right away.

Directions

Surgical scrub

  • remove jewelry
  • clean nails with an orangewood stick
  • wet hands and forearms with water and apply 5 ml of the product
  • wash/scrub hands and forearms for 5 minutes paying particular attention to nails, cuticles, and interdigital spaces
  • rinse thoroughly with water
  • wet hands and forearms with water and apply 5 ml of the product
  • wash hands and forearms for 5 minutes
  • rinse thoroughly with water

____________________________________________________________________

Antiseptic handwash

  • wet hands and forearms
  • dispense a palmful of product to hands
  • scrub hands and forearms for 20 seconds
  • rinse thoroughly and dry

Other information

  • for additional information, see Material Safety Data Sheet
  • for emergency medical information in USA and Canada, call 1-800-328-0026

Inactive ingredients

water (aqua), propylene glycol, ammonium nonoxynol-4 sulfate, ethanol, sodium citrate, hydroxyethylcellulose

Questions?

call1.866.781.8787, 24 hours a day, 7 days a week

Principal Display Panel / Representative Label

ECOLAB

NDC 47593-484-32

IODINE SURGICAL SCRUB

Active Ingredient: Povidone Iodine 7.5%

6084332

Net Contents: 1000 mL (33 US fl oz)

Representative Label

ECOLAB 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-484
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47593-484-321000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/27/201105/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/27/201105/04/2020
Labeler - Ecolab Inc. (006154611)

Revised: 12/2018
 
Ecolab Inc.