Label: SOVEREIGN SILVER - silver gel

  • NDC Code(s): 52166-002-01, 52166-002-02
  • Packager: Natural Immunogenics Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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  • ACTIVE INGREDIENT

    Ingredients: ACTIVE:

    Argentum Metallicum 10x, 20x and 30x HPUS

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  • INACTIVE INGREDIENT

    INACTIVE: Silver hydrosol,

    carbopol and sodium hydroxide


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  • PURPOSE

    Purpose

    First Aid Gel

    Homeopathic medicine

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Adult supervision required

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  • WARNINGS

    Warnings. For external

    use only. Ask a doctor before use if

    you have deep or puncture wounds, animal bites or serious burns.

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  • ASK DOCTOR

    Stop and ask a doctor if

    symptoms persist or worsen after 3 days of use. Do not use if

    seal is broken

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  • DOSAGE & ADMINISTRATION

    Enter section text here Directions. Clean affected area.

    Apply a liberal, consistent layer of First Aid Gel. Leave wet or bandage for

    optimal results. Repeat 3 times per day or as often as needed to relieve symptoms.

    For sensitive skin.

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  • INDICATIONS & USAGE

    Indications for Use: For relief of these symptoms due to

    minor wounds and burns, bruises, ulcerations, sunburn, razor burns,

    scrapes, rashes, blisters, bug bites and skin eruptions from acne, eczema

    or minor infection:

    burning

    stinging

    itching

    redness

    stiffness

    minor pain

    minor inflammation

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  • INGREDIENTS AND APPEARANCE
    SOVEREIGN SILVER  
    argentum metallicum gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52166-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Silver (Silver) Silver 30 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    Sodium hydroxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52166-002-02 1 in 1 BOX
    1 NDC:52166-002-01 1 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/01/2009
    Labeler - Natural Immunogenics Corp. (048744085)
    Registrant - Natural Immunogenics Corp. (048744085)
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