Label: EAR CARE EARACHE DROPS- atropa belladonna, anemone pulsatilla, lycopodium clavatum spore, matricaria chamomilla, and sulfur liquid

  • 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 March 16, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates the components of this product are officially monographed in the Homeopathic Pharmacopœia of the United States.
    Belladonna 30C HPUSFever
    Calcarea Carbonica 30C HPUSThrobbing ear pain
    Chamomilla 30C HPUSSleeplessness and irritability
    Lycopodium 30C HPUSEar pain
    Pulsatilla 30C HPUSEar itching, pain worse at night
    Sulphur 30C HPUSEar pain with burning
  • Uses*

    • For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of fever, pain, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common pain and itching of “swimmers ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • Warnings

    USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. Keep away from eyes. This product is intended to complement, not replace, standard medical treatment. Initial worsening of symptoms may occur. A physician should always be consulted to rule out serious causes.

    If pregnant or breast feeding, ask a health professional before use.

    Stop and ask a doctor it:

    • Symptoms worsen or continue for more than 48 hours
    • There is discharge from the ear.
    • A fever of greater than 102° is present

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Do not use: if you have ear drainage, irritation, discharge, or rash in the ear, consult a physician. With ear tubes, with damaged ear drums or after surgery. if drops become cloudy.

  • Directions

    Suitable for adults and children over the age of 2.

    • For use in the ears only

    • Remove any hearing aids

    • Use 3-5 drops twice per day or as needed. Warm contents to body temperature by holding bottle in your hands. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in. Tilt your head to the side and let solution drip into the ear. Never put the tip in the ear canal. Keep drops in your ear by tilting your head for 1-2 minutes or gently place cotton in the ear to keep drops in.

  • Inactive ingredients

    Benzalkonium Chloride, Citric Acid, Glycerine, Purified Water

  • Questions or comments?

    (800) RITE-AID

    (800-748-3243)

  • Other Information:

    Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopeia of the United States and are therefore non-toxic with no known side effects.

    • Store at 15°C-30°C (59°F-86°F)
    • Protect from light and excessive moisture

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    NDC 11822-3644-3

    ear care

    earache drops

    homeopathic


    eases pain

    calms and soothes

    relieves itching due to

    cold & flu, swimmers

    ear & allergy

    0.33 FL. OZ. (10 mL)

    External box

  • INGREDIENTS AND APPEARANCE
    EAR CARE EARACHE DROPS 
    atropa belladonna, anemone pulsatilla, lycopodium clavatum spore, matricaria chamomilla, and sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3644
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA30 [hp_C]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3644-31 in 1 CARTON08/03/2017
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/03/2017
    Labeler - Rite Aid Corporation (014578892)
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