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Iodophor Surgical Hand Scrub

Dosage form: soap
Ingredients: POVIDONE-IODINE 390mg in 1g
Labeler: Pharmalab Enterprises Inc.
NDC Code: 14505-505

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.

DRUM LABEL

Iodine Soap


Lot Number: "Specific Lot #"

Date: "Date of Packaging"

Ref Number: "Specific Reference Number"

Weight: "Weight of Drum"

Tare Weight: "Specific Tare Weight"


Volume: 52 Gallons US




***PLEASE NOTE  - Each label varies according to the specifications of the shipment. Thus, all values listed in parentheses vary by individual label.***

Active Ingredient:                                  Purpose

Povidone Iodine 7.5%w/w ................................   Antiseptic

Inactive Ingredients:Lauric Diethanolamide, Ammonium Lauryl Sulfate, Glyceryl Cocoate, Panthenol, Sodium Hyrdoxide, Potassium Iodate, Water

Uses:Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.

Directions:

Clean under the nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Apply a palmful (5g) of foam to hands and forearms. Scrub thoroughly for 2 minutes with a sterile scrub brush, paying particular attention to the nails, cuticles, and interdigital spaces. Rinse and repeat scrub.

Warnings: For External use only

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. Avoid contact with eyes: In case of contact, flush eyes with water

Stop use and ask a doctor if irritation or redness develops.

IODOPHOR  SURGICAL HAND SCRUB
povine-iodine soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14505-505
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE390 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LAURIC DIETHANOLAMIDE 
AMMONIUM LAURYL SULFATE 
GLYCERYL COCOATE 
PANTHENOL 
SODIUM HYDROXIDE 
POTASSIUM IODATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:14505-505-99200000 g in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/11/2010
Labeler - Pharmalab Enterprises Inc. (174401088)

Revised: 09/2010
 
Pharmalab Enterprises Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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