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

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EAR RELIEF (CHAMOMILLA AND MERCURIUS SOLUBILIS AND SULPHUR) SOLUTION [SIMILASAN CORPORATION]
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NDC 59262-271-11
Set ID eb553b17-08b1-4718-a612-16207e8b7bdf
Category HUMAN OTC DRUG LABEL
Packager Similasan Corporation
Generic Name
Product Class
Product Number
Application Number
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  • Active ingredient

    Chamomilla 10X

  • Purpose

    sensitivity to drafts, soothing

  • Active ingredient

    Mercurius solubilis 15X

  • Purpose

    fullness, sensitivity to cold

  • Active ingredient

    Sulphur 12X

  • Purpose

    itchiness, sensitivity to water

  • Uses:

    Helps temporarily relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.

  • Warnings:

    • Do not use in the eyes.
    • Initial exacerbation of symptoms may occur.

    Ask a doctor before use if you have:

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

    Stop use and ask a doctor if:

    • irritation (too much burning) or pain occurs
    • symptoms persist for more than 48 hours

    If 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.

  • Directions:

    FOR USE IN THE EAR ONLY

    • Remove tamper-evident seal from neck of bottle.
    • Twist cap off bottle.
    • Tilt head sideways.
    • Squeeze plastic applicator and apply 4 to 5 drops in each affected ear (applicator should not enter ear canal).
    • Keep drops in ear by keeping head tilted or placing cotton in 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

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-271-11
    Similasan
    Ear Relief
    EAR DROPS
    10 ml / 0.33 fl oz

    NDC 59262-271-11 Similasan Ear Relief EAR DROPS 10 ml / 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    EAR RELIEF 
    chamomilla and mercurius solubilis and sulphur solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-271
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE10 [hp_X]  in 10 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS15 [hp_X]  in 10 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-271-1110 mL in 1 BOTTLE, GLASS; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC07/02/2013
    Labeler - Similasan Corporation (111566530)
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