Label: SOVEREIGN SILVERBIO-ACTIVE SILVER BIO-ACTIVE SILVER HYDROSOL- silver liquid

  • NDC Code(s): 52166-003-01, 52166-003-02, 52166-003-03, 52166-003-04, view more
    52166-003-05, 52166-003-06, 52166-003-07
  • Packager: Natural Immunogenics Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

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 12/14

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient:  Silver

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  • INACTIVE INGREDIENT

    Inactive Ingredient

    water

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  • PURPOSE

    Silver has a long history of safe

    use in a diverse range of applications on heathcare,

    personal hygiene (including feminine douching) and

    water purification.

     

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  • KEEP OUT OF REACH OF CHILDREN

    Enter section text here

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  • INDICATIONS & USAGE

    Silver has a long history of safe

    use in a diverse range of applications in healthcare,

    personal hygiene (including feminine douching) and

    water purification.

    Can also be used on animals and plants affected by fungus,

    bacteria or viruses. Apply or spray as needed.

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  • DOSAGE & ADMINISTRATION

    Apply topically as necessary. Use

    droppers for ears and nostrils. For oral use, swish 1

    or 2 teaspoons around the mouth for 1 to 2 minutes,

    then expel.

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  • WARNINGS

    Precautions: There are no known safety issues

    associated with typical use of this product for adults,

    children, animal or plants. In the event of oral

    consumption, the US Environmental Protection Agency

    has established a daily oral Reference Dose for silver

    ingestion at 350 ug / day, over a 70 - year lifetime.

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  • INGREDIENTS AND APPEARANCE
    SOVEREIGN SILVERBIO-ACTIVE SILVER  BIO-ACTIVE SILVER HYDROSOL
    silver liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52166-003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Silver (UNII: 3M4G523W1G) (Silver - UNII:3M4G523W1G) Silver 0.01 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52166-003-01 .6 mL in 1 BOTTLE
    2 NDC:52166-003-02 1.2 mL in 1 BOTTLE
    3 NDC:52166-003-03 2.4 mL in 1 BOTTLE
    4 NDC:52166-003-04 4.8 mL in 1 BOTTLE
    5 NDC:52166-003-05 19.2 mL in 1 BOTTLE
    6 NDC:52166-003-06 3785 mL in 1 BOTTLE
    7 NDC:52166-003-07 3785 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 08/15/2012
    Labeler - Natural Immunogenics Corp. (048744085)
    Establishment
    Name Address ID/FEI Business Operations
    Natural Immunogenics Corp. 048744085 manufacture(52166-003)
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