Label: RITE AID EAR DROPS- 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 August 25, 2010

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  • Active ingredient

    Chamomilla 10X

  • Purpose

    calmative, pain reliever

  • Active ingredient

    Mercurius solubilis 15X

  • Purpose

    pain reliever

  • Active ingredient

    Sulphur 12X

  • Purpose

    pain reliever, anti-itch

  • Uses:

    According to homeopathic principles, the active ingredinets in this medication provide temporary relief from earache (ear pain) in children and adults due to:

    - Drafts
    - Colds
    - Flu
    - Swimmer's ear

  • Warnings:

    - For external use only
    - A physician should be consulted about earache in children.
    - Initial exacerbation of symptoms may occur.
    - Keep this and all medicines out of the reach of children.
    - If swallowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children

    Keep this and all medicines out of the reach of children

  • Do not use:


    - If you have ear drainage, discharge, irritation, a rash in the ear, or are dizzy; consult a doctor.
    - With ear tubes, after ear surgery or with damaged ear drums.
  • Stop use and ask a doctor if:


    - Symptoms persist for more than 48 hours.
    - These is discharge from the ear.
    - There is a fever of 102F or greater.
  • Directions:


    FOR USE IN THE EAR ONLY
    For adults and children, including toddlers and infants:
    - Remove tamper-evident seal from neck of bottle.
    - Twist cap off bottle.
    - Tilt head sideways.
    - Squeeze plastic applicator to release 2-3 drops into ear (applicator should not enter ear canal).
    - Keep drops in ear by keeping head tilted or placing cotton in ear.
    - Repeat as needed, use when pain reoccurs.

  • Other information:

    Active ingredients are manufactured according to homeopathic principles and are therefore non-toxic and have no known side effects.

  • Inactive ingredient:

    Vegetable Glycerin
  • Principle Display Panel

    Rite Aid Ear Drops
    Homeopathic
    Earache Remedy
    10 ml/ 0.33 fl oz

    Rite Aid Earache Box

    Rite Aid Earache Box















  • INGREDIENTS AND APPEARANCE
    RITE AID EAR DROPS 
    chamomilla and mercurius solubilis and sulphur solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9002
    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:11822-9002-710 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/01/2006
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Similasan AG (481545754)
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