KIDS EAR RELIEF (MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, ANEMONE PATENS AND SULPHUR) SOLUTION [SIMILASAN CORPORATION]

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  • KIDS EAR RELIEF (MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, ANEMONE PATENS AND SULPHUR) SOLUTION [SIMILASAN CORPORATION]

KIDS EAR RELIEF (MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, ANEMONE PATENS AND SULPHUR) SOLUTION [SIMILASAN CORPORATION]
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NDC 59262-273-11
Set ID 1b7cbef3-df1b-4717-9ea9-bd963cb3b553
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

    Pulsatilla 12X      

  • Purpose

    night time calmative

  • Active ingredient

    Sulphur 12X      

  • Purpose

    itchiness, sensitivity to water

  • Uses:

    Helps 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 the child has:

    • 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
  • 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.

    For children ages 2 and over:

    • Remove tamper-evident seal from neck of bottle.
    • Twist cap off bottle.
    • Tilt child’s 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.
  • Other information:

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive ingredient:

    Vegetable glycerin

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-273-11
    Similasan
    Kids Ear Relief
    EAR DROPS
    10 ml / 0.33 fl oz

    NDC 59262-273-11 Similasan Kids Ear Relief EAR DROPS 10 ml / 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    KIDS EAR RELIEF 
    matricaria recutita, mercurius solubilis, anemone patens and sulphur solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-273
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 10 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS15 [hp_X]  in 10 mL
    ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD) ANEMONE PATENS12 [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:59262-273-111 in 1 BOX
    110 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/15/2014
    Labeler - Similasan Corporation (111566530)
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