Label: BIO IODINE- iodium liquid

  • NDC Code(s): 43857-0088-1
  • Packager: BioActive Nutritional, 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 August 11, 2016

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  • ACTIVE INGREDIENTS:

    Iodium 6X.

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  • INDICTIONS:

    For temporary relief of symptoms due to lowered metabolism and hypothyroidism.

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  • WARNINGS:

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in cool, dry place.

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  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

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  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

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  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS:

    For temporary relief of symptoms due to lowered metabolism and hypothyroidism.

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  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

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  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    BIO IODINE

    HOMEOPATHIC

    1 FL OZ  (30 ml)

    Bio Iodine

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  • INGREDIENTS AND APPEARANCE
    BIO IODINE 
    iodium liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0088
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43857-0088-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/11/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 02/13/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0088) , api manufacture(43857-0088) , label(43857-0088) , pack(43857-0088)
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