Label: SILICEA- silicon dioxide tablet, chewable

  • NDC Code(s): 60512-8034-5, 60512-8034-6
  • Packager: HOMEOLAB USA INC
  • 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 03/14

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  • Active ingredients HPUS

    Silicea (Silica) 12X

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  • Purpose

    ...........................................Skin eruptions, brittle nails, dull hair

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  • REFERENCES

    The letters 'HPUS' indicate that the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States.

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  • Uses

    This tissue salt helps relieve symptoms associated with skin eruptions and irritations, brittle, splitting nails and dull, brittle hair.*

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

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  • Warnings

    Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

    As with any drug, ask a doctor before use if pregnant or nursing.

    Keep this and all medications out of the reach of children.

    In case of emergency or accidental overdose, contact a medical professional or a Poison Control Center immediately.

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  • Directions

    Children from 2 to 5 years: Crush 2 tablets and dissolve in water 3 times daily, or as directed by a healthcare professional.

    Adults and children over 5 years: Chew 2 tablets 3 times daily, or as directed by a healthcare professional.


    • Do not use more than directed.

    • Do not take with food.

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  • Other information

    Store at room temperature.

    Do not use if cap seal is broken or missing.

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  • Inactive ingredients

    Lactose, magnesium stearate.

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  • LABEL
  • INGREDIENTS AND APPEARANCE
    SILICEA 
    silicea tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:60512-8034
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SILICON DIOXIDE (COLLOIDAL SILICON DIOXIDE) SILICON DIOXIDE 12 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code NONE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60512-8034-5 125 in 1 JAR
    2 NDC:60512-8034-6 500 in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/26/2014
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    Name Address ID/FEI Business Operations
    HOMEOLAB USA INC 202032533 manufacture(60512-8034)
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