Label: EARACHE RELIEF- chamomilla and mercurius solubilis and sulphur 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 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients -

    Chamomilla 10X

    Mercurius solubilis 15X

    Sulphur 12X

  • Purpose

    pain, sensitivity to drafts, soothing

    pain, fullness, sensitivity to cold

    pain, 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 water and drafts

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

  • 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. 1-800-222-1222

    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

    Vegetable glycerin

  • PRINCIPAL DISPLAY PANEL


    Earache Relief
    Ear Drops

    0.33 FL OZ (10 mL)

    PRINCIPAL DISPLAY PANEL Earache Relief Ear Drops 0.33 FL OZ (10 mL)

  • INGREDIENTS AND APPEARANCE
    EARACHE RELIEF 
    chamomilla and mercurius solubilis and sulphur solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53799-406
    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:53799-406-1110 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/03/2023
    Labeler - Similasan AG (481545754)
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