Label: CHILDRENS EARACHE RELIEF- chamomilla 10x, mercurius solubilis 15x, pulsatilla 12x, sulphur 12x 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 April 22, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts – Children’s Earache Relief

  • Active ingredients

    Chamomilla 10X

    Mercurius solubilis 15X

    Pulsatilla 12X

    Sulphur 12X

  • Purpose

    sensitivity to drafts, soothing

    fullness, sensitivity to cold

    night time calmative

    itchiness, sensitivity to water

  • Uses*

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

    • sensation of fullness of the ear

    • sensitivity to cold, drafts, and water

    • the annoyance of water-clogged ears by helping clear water trapped in the ear

  • Warnings

    • Do not use in the eyes.

    Children under 2 years of age should be seen by a physician.

    • 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 the child has:

    • ear drainage or discharge

    • pain, irritation, or rash in the ear

    • had ear surgery

    • dizziness

  • 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.

    • DON'T squeeze bottle, squeeze plastic tip to release 3-5 drops into ear (tip of applicator should not enter ear canal).

    • Keep drops in ear for 3-5 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.

  • 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

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-274-11
    Similasan
    Children’s
    Earache
    Relief
    EAR DROPS
    10 ml / 0.33 fl oz

    PRINCIPAL DISPLAY PANEL NDC 59262-274-11 Similasan Children’s Earache Relief EAR DROPS 10 ml / 0.33 fl oz

    PRINCIPAL DISPLAY PANEL NDC 59262-274-11 Similasan Children’s Earache Relief EAR DROPS 10 ml / 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    CHILDRENS EARACHE RELIEF 
    chamomilla 10x, mercurius solubilis 15x, pulsatilla 12x, sulphur 12x solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-274
    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
    PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA PATENS WHOLE12 [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:59262-274-1110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2007
    Labeler - Similasan Corporation (111566530)
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