Label: KALI IODATUM 1X- potassium iodide liquid

  • NDC Code(s): 43406-0094-1
  • Packager: Natural Creations, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 19, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient (HPUS*): Kali Iodatum 1X

  • PURPOSE

    Uses:  Temporarily relieves swelling with pain.**

  • INDICATIONS & USAGE

    Uses:  Temporarily relieves swelling with pain.**

  • DOSAGE & ADMINISTRATION

    Directions:  Adults & children above 12 years:  1 drop orally once daily, or as directed by a health care professional.

  • KEEP OUT OF REACH OF CHILDREN

    WARNINGS:

    • Consult a physician for use in children under 12 years of age.
    • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
    • KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion)   get    medical help or contact a Poison Control Center right away.
    • Do not use if TAMPER EVIDENT seal is broken or missing.
  • WARNINGS

    WARNINGS:

      *Consult a physician for use in children under 12 years of age.

      * IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

      * KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion)   get    medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Ethyl Alcohol USP, Glycerin USP, Purified Water.

  • QUESTIONS

    Questions & Comments?

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

    * The letters "HPUS" indicate the component in this product is officially monographed in the Homeopathic Pharmacopeia of the United States.

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0094-1

    KALI IODATUM 1X

    HOMEOPATHIC

    1 fl oz (30 mL) 5% Alcohol

    UPC: 877730003881

    image description

  • INGREDIENTS AND APPEARANCE
    KALI IODATUM 1X 
    potassium iodide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0094
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0094-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/29/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2007
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0094)