Label: IODINE- iodine alcoholic solution

  • NDC Code(s): 16638-166-38
  • Packager: Borisovskiy Zavod Medicinskikh Preparatov JSC
  • 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

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  • Purpose

    Bactericidial - antiseptic

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  • Uses

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

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • Directions

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

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  • Other information

    Keep in a dark place at temperature below 25 oC.

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  • Inactive ingredients

    Ethanol, Purified Water

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  • INGREDIENTS AND APPEARANCE
    IODINE 
    iodine alcoholic solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16638-166
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 0.5 g  in 10 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 0.2 g  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    ETHANOL, 2-(BIS(2-METHYLPROPYL)PHENOXY)- (UNII: AUK0O5KW1Y) 10 mL  in 10 mL
    WATER (UNII: 059QF0KO0R) 10 mL  in 10 mL
    Product Characteristics
    Color brown (Transparent red-brown liquid) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16638-166-38 10 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 10/20/1999
    Labeler - Borisovskiy Zavod Medicinskikh Preparatov JSC (628149593)
    Establishment
    Name Address ID/FEI Business Operations
    Borisovskiy Zavod Medicinskikh Preparatov JSC 628149593 manufacture(16638-166)
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