Label: TINNITUS CONTROL- not applicable 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 October 14, 2014

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

  • ACTIVE INGREDIENTS:

    ARNICA MONTANA 30X,  CHININUM SULPHURICUM 30X,  FERRUM METALLICUM 30X,  KALI PHOSPHORICUM 30X,  NATRUM SULPHURICUM 30X,  PULSATILLA (VULGARIS) 30X,  SILICEA 30X,  THIOSINAMINUM 30X

  • INDICATIONS:

    Helps relieve symptoms of Tinnitus.

  • WARNINGS:

    If pregnant or breast-feeding, seek the advice of a doctor before use. Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

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

    Do not use if tamper evident seal around neck of bottle is missing or broken.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Adults and Children over 12: Spray twice under the tongue 3 times per day.

    Children under 12: Consult a doctor prior to use.

  • INDICATIONS:

    Helps relieve symptoms of Tinnitus.

  • INACTIVE INGREDIENTS:

    Alcohol 20% v/v, Purified water.

  • QUESTIONS:

    Distributed by:

    Pacific Naturals

    PO Box 7574

    Milton Keynes

    MK11 9GQ, United Kingdom

  • PACKAGE LABEL DISPLAY:

    Tinnitus

    Control

    Helps relieve the

    symptoms of Tinnitus

    HOMEOPATHIC

    1.0 fl. oz. (30 ml), 20% alcohol

    TINNITUS CONTROL

  • INGREDIENTS AND APPEARANCE
    TINNITUS CONTROL 
    not applicable liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43695-0009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 mL
    QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A) QUININE SULFATE30 [hp_X]  in 1 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON30 [hp_X]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC30 [hp_X]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE30 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 mL
    ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43695-0009-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/14/2014
    Labeler - Pacific Naturals (184784283)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43695-0009) , api manufacture(43695-0009) , label(43695-0009) , pack(43695-0009)