Label: SOVEREIGN SILVER- argentum metallicum gel

  • NDC Code(s): 52166-002-01, 52166-002-02, 52166-002-03
  • Packager: Natural Immunogenics Corp.
  • Category: HUMAN OTC DRUG LABEL

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 October 20, 2023

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  • ACTIVE INGREDIENT

    Ingredients: ACTIVE:

    Argentum Metallicum 10x, 20x and 30x HPUS

  • INACTIVE INGREDIENT

    INACTIVE: Silver hydrosol,

    carbopol and sodium hydroxide


  • PURPOSE

    Purpose

    First Aid Gel

    Homeopathic medicine

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Adult supervision required

  • WARNINGS

    Warnings. For external

    use only. Ask a doctor before use if

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

  • ASK DOCTOR

    Stop and ask a doctor if

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

    seal is broken

  • 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.

  • 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

  • 52166-002-01

    image description

  • 52166-002-02

    image description

  • 52166-002-03

    image description

  • INGREDIENTS AND APPEARANCE
    SOVEREIGN SILVER  
    argentum metallicum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52166-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52166-002-011 in 1 BOX01/01/2009
    129 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:52166-002-021 in 1 BOX01/01/2009
    259 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:52166-002-035 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2009
    Labeler - Natural Immunogenics Corp. (048744085)
    Registrant - Natural Immunogenics Corp. (048744085)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Immunogenics Corp.048744085manufacture(52166-002)
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