Label: TINNITUS DROPS 2072- tinnitus drops liquid

  • 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 August 15, 2019

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  • ACTIVE INGREDIENTS

    Cimicifuga racemosa 1X
    Ginkgo biloba 1X
    Cinchona officinalis 3X, 6X, 12X, 30X
    Hydrastis canadensis 5X
    Ear 6X, 12X, 30X
    Lycopodium clavatum 6X, 12X
    Major nerves 6X, 12X, 30X
    Sulphur 6X, 12X
    Digitalis purpurea 12X
    Kali carbonicum 30X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of noise in the ears, such as ringing, roaring, buzzing, hissing, or whistling.*

  • PURPOSE

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS

    Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, persistent headache, dizziness, or loss of hearing, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

    Keep out of the reach of children.

    If pregnant or breastfeeding, ask a healthcare professional before use.

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    20% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Tinnitus Drops

    Homeopathic Remedy

    2 FL. OZ. (59 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    TINNITUS DROPS  2072
    tinnitus drops liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-2072
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH1 [hp_X]  in 59 mL
    GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO1 [hp_X]  in 59 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK3 [hp_X]  in 59 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 59 mL
    SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV) SUS SCROFA EAR6 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE6 [hp_X]  in 59 mL
    BOS TAURUS NERVE (UNII: 28G2U3MQJK) (BOS TAURUS NERVE - UNII:28G2U3MQJK) BOS TAURUS NERVE6 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]  in 59 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS12 [hp_X]  in 59 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE30 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-2072-259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-2072)