Label: FOAM SAFE- povidone iodine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated April 17, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient                   Purposes

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

  • PURPOSE

    Uses

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


  • WARNINGS

    Warnings

    For External Use Only

    Stope use and ask doctor if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    FoamSafeLabel

  • INDICATIONS & USAGE

    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.

  • INGREDIENTS AND APPEARANCE
    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)
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