Label: TINNITUS FORMULA (cimicifuga racemosa, ginkgo biloba, cinchona officinalis, hydrastis canadensis, lycopodium clavatum, sulphur, cerebellum (suis), ear- suis digitalis purpurea, kali carbonicum spray

  • NDC Code(s): 83027-0006-1
  • Packager: Nutritional Specialties, Inc.
  • 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 April 6, 2023

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

  • ACTIVE INGREDIENTS:

    Cimicifuga Racemosa 2X, Ginkgo Biloba 2X, Cinchona Officinalis 3X, 6X, 12X, 30X, Hydrastis Canadensis 6X, Lycopodium Clavatum 6X, 12X, Sulphur 6X, 12X, Cerebellum 6X, 12X, 30X, Ear 6X, 12X, 30X, Digitalis Purpurea 12X, Kali Carbonicum 30X.

  • PURPOSE:

    Provides homeopathic assistance in relieving symptoms associated with tinnitus such as ringing in the ears, noises, and dizziness.†

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

  • WARNINGS:

    Professional Use Only

    If pregnant or breast-feeding, ask a health professional before use.

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

    If condition worsens, seek medical attention.

    KEEP OUT OF REACH OF CHILDREN

    Do not use if tamper evident seal is broken or missing.

    Store in a cool place after opening

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    Provides homeopathic assistance in relieving symptoms associated with tinnitus such as ringing in the ears, noises, and dizziness.†

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

  • INACTIVE INGREDIENTS:

    Alcohol USP 20%, Purified Water USP.

  • QUESTIONS:

    MANUFACTURED EXCLUSIVELY FOR

    NUTRITIONAL SPECIALTIES, INC.

    PO BOX 97227

    PITTSBURG, PA 15229

    www.phpltd.com

  • PACKAGE LABEL DISPLAY:

    Professional

    Health Products

    HOMEOPATHIC

    NDC 83027-0006-1

    TINNITUS

    FORMULA

    2 FL. OZ (60 ml)

    TINNITUS  FORMULA

  • INGREDIENTS AND APPEARANCE
    TINNITUS FORMULA 
    cimicifuga racemosa, ginkgo biloba, cinchona officinalis, hydrastis canadensis, lycopodium clavatum, sulphur, cerebellum (suis), ear (suis) digitalis purpurea, kali carbonicum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH2 [hp_X]  in 1 mL
    GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO2 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]  in 1 mL
    SUS SCROFA CEREBRUM (UNII: 4GB5DQR532) (SUS SCROFA CEREBRUM - UNII:4GB5DQR532) SUS SCROFA CEREBRUM6 [hp_X]  in 1 mL
    SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV) SUS SCROFA EAR6 [hp_X]  in 1 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS12 [hp_X]  in 1 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83027-0006-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/10/2023
    Labeler - Nutritional Specialties, Inc. (032744609)