Label: SOVEREIGN SILVER- argentum metallicum gel

  • NDC Code(s): 52166-015-01, 52166-015-02, 52166-015-03
  • Packager: Natural Immunogenics Corp.
  • 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 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

    Natural healing gel skin care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • 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

    Directions

    Gently clean affected area. Apply a liberal, consistent layer of Skin Care Gel over affected area. Repeat 3 times per day or as often as needed to relieve symptoms. Safe on sensitive skin.

  • INDICATIONS & USAGE

    Indications for Use

    For relief of symptoms due to skin eruptions from acne, eczema, minor infection, rashes, blisters -Sunburn – Razor Burn – minor nicks & cuts – redness – minor inflammation

  • Product label

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  • INGREDIENTS AND APPEARANCE
    SOVEREIGN SILVER  
    argentum metallicum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52166-015
    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:52166-015-0129 mL in 1 TUBE; Type 0: Not a Combination Product12/20/2022
    2NDC:52166-015-0259 mL in 1 TUBE; Type 0: Not a Combination Product12/20/2022
    3NDC:52166-015-03118 mL in 1 TUBE; Type 0: Not a Combination Product12/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/20/2022
    Labeler - Natural Immunogenics Corp. (048744085)
    Registrant - Natural Immunogenics Corp. (048744085)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Immunogenics Corp.048744085manufacture(52166-015)
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