Label: ASPERGILLUS- aspergillus niger var. niger liquid

  • 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 December 23, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Medicine

  • Indications

    For temporary relief of external urogenital soreness / itching

  • Dosage

    5-10 drops, three times daily.

  • Active Ingredient

    Aspergillus niger 4X

  • Inactive Ingredients

    Purified water, sodium chloride, potassium sorbate.

  • Warning

    If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing, seek the advice of a health care professional before using this product.

    Keep this and all medications out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • Tamper Evident

    Do not use product if the tamper evident strip is broken or removed from the base of the cap.

  • SPL UNCLASSIFIED SECTION

    To report serious adverse events, call: 1-877-557-4276 or 1-623-582-3110

    Manufactured for and distributed by:
    USPharmaCo Distribution Ltd.
    2205 W. Lone Cactus Drive #19,
    Phoenix, AZ 85027
    www.uspharmaco.com
    info@uspharmaco.com

    Made in Canada

  • PRINCIPAL DISPLAY PANEL - 10 mL Label

    ASPERGILLUS DROPS 4X

    Homeopathic Medicine 0.34 fl. oz. (10ml)

    Indications: For temporary relief of external urogenital soreness / itching
    Dosage: 5-10 drops, three times daily.
    Active Ingredient: Aspergillus niger 4X
    Inactive Ingredients: Purified water, sodium chloride, potassium sorbate.
    Warning: If symptoms persist more than a few days, contact a licensed practitioner. As with
    any drug, if you are pregnant or nursing, seek the advice of a health care professional before
    using this product. Keep this and all medications out of reach of children. In case of overdose,
    get medical help or contact a Poison Control Center right away. Protect from light and heat.
    Tamper Evident: Do not use product if the tamper evident strip is broken or removed from the
    base of the cap.
    To report serious adverse events, call: 1-877-557-4276 or 1-623-582-3110

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ASPERGILLUS 
    aspergillus niger var. niger liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49693-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aspergillus niger var. niger (UNII: 9IOA40ANG6) (Aspergillus niger var. niger - UNII:9IOA40ANG6) Aspergillus niger var. niger4 [hp_X]  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49693-1001-11 in 1 BOX
    110 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/15/2009
    Labeler - USPharmaCo (145322622)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaMed256799461MANUFACTURE
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