EAR RINGING REMEDY (CHAMOMILLA AND MERCURIUS SOLUBILIS AND SULPHUR) SOLUTION [SIMILASAN CORPORATION]

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EAR RINGING REMEDY (CHAMOMILLA AND MERCURIUS SOLUBILIS AND SULPHUR) SOLUTION [SIMILASAN CORPORATION]
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NDC 59262-275-11
Set ID 6451c91d-ea16-484a-be11-5311434ee8db
Category HUMAN OTC DRUG LABEL
Packager Similasan Corporation
Generic Name
Product Class
Product Number
Application Number
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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
    tinkling, buzzing
    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, chirping

  • Uses*

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

    • 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.

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

    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 4 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

    Vegetable glycerin, purified water

  • Questions?

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

    www.SimilasanUSA.com

    *These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration

  • Principal Display Panel

    NDC 59262-275-11
    Similasan
    Ear Ringing Remedy
    10 mL/ 0.33 fl oz

    NDC 59262-275-11 Similasan Ear Ringing Remedy 10 mL/ 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    EAR RINGING REMEDY 
    chamomilla and mercurius solubilis and sulphur solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-275
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-275-1110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/01/2018
    Labeler - Similasan Corporation (111566530)
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