FOAM SAFE (POVIDONE IODINE) LIQUID [GREMED MANUFACTURING LLC]

FOAM SAFE (POVIDONE IODINE) LIQUID [GREMED MANUFACTURING LLC]
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NDC 47066-402-01, 47066-402-02, 47066-402-03, 47066-402-04, 47066-402-05, 47066-402-06
Set ID c3f2c30b-e222-4772-9016-886051200934
Category HUMAN OTC DRUG LABEL
Packager Gremed Manufacturing LLC
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333C
  • 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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