Label: EAR RINGING REMEDY- allylthiourea, arnica montana flower, calcium sulfide, eriodictyon californicum leaf, lachesis muta venom, lycopodium clavatum spore, quinine sulfate, silica dimethyl silylate solution

  • 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 March 11, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Arnica 15X
    Chininum sulphuricum12X
    Eriodictyon californicum 12X
    Hepar 12X
    Lachesis 15X
    Lycopodium 12X
    Silica15X
    Thiosinaminum 15X

  • Purpose

    buzzing
    ringing, humming
    ear discomfort, dizziness
    pulsations/pounding, buzzing
    throbbing, tinkling, roaring, cracking, buzzing, rolling, whizzing, resounding noise in ears
    ringing, tinkling, buzzing, roaring, humming, whizzing in the ears
    tinkling, clucking, roaring, singing, noises in ear
    ringing

  • Uses*

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms associated with ear discomfort due to:

    • ringing       • buzzing       • roaring

    • humming       • pounding

  • Warnings

    • Do not use in the eyes.
    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)

    If pregnant, trying to get pregnant or breast feeding, 

    ask a health professional before use.

    Keep out of reach of children.  

    If swallowed, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if:

    • symptoms persist for more than 48 hours
    • there is discharge from the ear
    • there is a fever of 102°F or greater

    Ask a doctor before use if you have:

    • ear drainage or discharge
    • pain, irritation, or rash in the ear
    • had ear surgery
    • dizziness
  • Directions

    FOR USE IN THE EAR ONLY.

    • Remove tamper-evident seal from neck of bottle.
    • Twist cap off bottle.
    • Tilt head sideways.
    • DON'T squeeze bottle, squeeze plastic tip to release 3 to 5 drops into ear (Tip of applicator should not enter ear canal).
    • Keep drops in ear for 3 to 5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear.
    • Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.
    • Children under 12 years of age consult a doctor.
  • Other information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive ingredient

    Purified water, Vegetable glycerin

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com

    www.SimilasanUSA.com

    For your protection do not use if tamper evident seal around neck of bottle is missing or broken.

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

  • Principal Display Panel


    Similasan
    Ear Ringing Remedy
    10 mL/ 0.33 fl oz

    Similasan Ear Ringing Remedy 10 mL/ 0.33 fl oz

    Similasan Ear Ringing Remedy 10 mL/ 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    EAR RINGING REMEDY 
    allylthiourea, arnica montana flower, calcium sulfide, eriodictyon californicum leaf, lachesis muta venom, lycopodium clavatum spore, quinine sulfate, silica dimethyl silylate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53799-275
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER15 [hp_X]  in 10 mL
    QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A) QUININE SULFATE12 [hp_X]  in 10 mL
    ERIODICTYON CALIFORNICUM LEAF (UNII: 2Y7TIQ135H) (ERIODICTYON CALIFORNICUM LEAF - UNII:2Y7TIQ135H) ERIODICTYON CALIFORNICUM LEAF12 [hp_X]  in 10 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 10 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 10 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 10 mL
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) (SILICA DIMETHYL SILYLATE - UNII:EU2PSP0G0W) SILICA DIMETHYL SILYLATE15 [hp_X]  in 10 mL
    ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA15 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53799-275-1110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/09/2021
    Labeler - Similasan AG (481545754)
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