Label: HUMCO 1 PERCENT IODINE- isopropyl alcohol liquid

  • 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 December 11, 2018

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  • SPL UNCLASSIFIED SECTION

    HUMCO 1% Iodine Tincture

    Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 70%

  • Purpose

    Topical antiseptic

  • Indications

    Preoperative skin preparation. Helps to reduce skin bacteria that potentially can cause skin infection.

  • Warnings:

    Flammable: Keep away from spark, heat or flame.

    Do not use with electrocautery procedures.

    For external use only.

    Do not use

    in the eyes  

    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

    IF ON SKIN: Wash with plenty of soap and water.

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If skin irritation or rash occurs of if eye irritation persists, get medical advice/attention. Take off contaminated clothing and wash before reuse.

    IN CASE OF FIRE: Use dry sand, dry chemical or alcohol resistant foam to extinguish. Store in well ventilated place. Keep cool. Dispose contents/container to an approved waste disposal plant.

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    • Use only by trained personnel.
    • Clean the affected area.
    • Apply product to operative site prior to surgery.
    • When this product dries remove immediately with 70% alcohol or as directed by a physician.
  • Other Information

    Will stain skin and clothing. Store at room temperature.

  • Inactive Ingredient

    Iodine 1%, Potassium iodide, Purified water.

  • PRINCIPAL DISPLAY PANEL

    capture

  • INGREDIENTS AND APPEARANCE
    HUMCO 1 PERCENT IODINE 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    IODINE (UNII: 9679TC07X4) 10 mg  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-1211-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/08/2017
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-1211) , pack(0395-1211) , analysis(0395-1211) , label(0395-1211)
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