Label: IODINE TINCTURE tincture

  • NDC Code(s): 65055-101-01, 65055-101-02
  • Packager: Laboratorios Jaloma, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • Active Ingredients

    Iodine 2.0%

    Sodium Iodide 2.4%

  • Purpose

    Antiseptic

    Antiseptic

  • Uses

    First aid to help prevent infection in *minor cuts *scrapes *burns

  • WARNINGS

    Warnings For external use only

  • DO NOT USE

    Do not use in the eyes or apply over large areas of

    the body

    Do not use longer than 1 week, unless directed by a

    doctor

  • ASK DOCTOR

    Consult a doctor in case of * deep or puncture

    wounds * animal bites * serious burns

  • STOP USE

    if the condition Stop use and consult a doctor

    persists or gets worse

  • KEEP OUT OF REACH OF CHILDREN

    In case of Keep out of the reach of children. 

    accidental ingestion, seek professional assistance

    or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    clean the affected area * apply a Directions 

    small amount of this product on the area 1 to 3

    times daily * may be covered with a sterile bandage

  • Inactive Ingredients

    alcohol, water

  • QUESTIONS

    Questions

    (33) 3617 5010 (In Guadalajara, Jal. Mexico)

  • Iodine Tincture Topical Antiseptic

    Image of Principal Display Panelimage description

  • INGREDIENTS AND APPEARANCE
    IODINE TINCTURE 
    iodine tincture tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65055-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE2 g  in 100 mL
    SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION2.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65055-101-0125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/24/2016
    2NDC:65055-101-0240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/24/201609/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00308/24/2016
    Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Jaloma, S.A. de C.V.811122357manufacture(65055-101)
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