FOAM SAFE - povidone iodine liquid 
Gremed Manufacturing 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                   Purposes

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

Uses

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


Warnings

For External Use Only

Stope use and ask doctor if irritation or redness develops.

Keep out of reach of children.

Directions

Clean under 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.

Inactive Ingredients

Water, Lauramide DEA, Ammonium Lauryl Sulfate, PEG-7, Glyceryl Cocoate, Panthenol, Sodium Hydroxide, Potassium Iodate

FoamSafeLabel

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.

FOAM SAFE 
povidone iodine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47066-402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE7.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
POLYETHYLENE GLYCOL 350 (UNII: ZBR3T82M2V)  
GLYCERYL COCOATE (UNII: WVK1CT5994)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POTASSIUM IODATE (UNII: I139E44NHL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47066-402-0159 mL in 1 BOTTLE
2NDC:47066-402-02118 mL in 1 BOTTLE
3NDC:47066-402-03473 mL in 1 BOTTLE
4NDC:47066-402-04500 mL in 1 BOTTLE
5NDC:47066-402-051000 mL in 1 BOTTLE
6NDC:47066-402-063785 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/01/2012
Labeler - Gremed Manufacturing LLC (832854041)

Revised: 4/2012
Document Id: 37d4cc31-7bb1-4d5c-b8b1-832d1a569d2f
Set id: c3f2c30b-e222-4772-9016-886051200934
Version: 2
Effective Time: 20120417
 
Gremed Manufacturing LLC