Label: IODINE- iodine alcoholic solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 26, 2015

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  • Active ingredients

    Iodine - 0.5 g, Potassium Iodide - 0.2 g

  • Purpose

    Bactericidial - antiseptic

  • Uses

    For inflammatory and infectious diseases of skin, cuts, minor injuries, wounds, myositis, neuraldia; for disinfection of the operational field.

  • Warnings

    For external use only.

    Avoid contact with eyes. If contact occurs, rinse eyes throughly with water.

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control center immediately.

  • Directions

    Apply to affected areas as needed or as directed by physician.

  • Other information

    Keep in a dark place at temperature below 25 oC.

  • Inactive ingredients

    Ethanol, Purified Water

  • PRINCIPAL DISPLAY PANEL

    image of vial labelimage of group label 1image of group label 2

  • INGREDIENTS AND APPEARANCE
    IODINE 
    iodine alcoholic solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16638-166
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE0.5 g  in 10 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION0.2 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHANOL, 2-(BIS(2-METHYLPROPYL)PHENOXY)- (UNII: AUK0O5KW1Y) 10 mL  in 10 mL
    WATER (UNII: 059QF0KO0R) 10 mL  in 10 mL
    Product Characteristics
    Colorbrown (Transparent red-brown liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16638-166-3810 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/20/1999
    Labeler - Borisovskiy Zavod Medicinskikh Preparatov JSC (628149593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Borisovskiy Zavod Medicinskikh Preparatov JSC628149593manufacture(16638-166)