Label: DOLOEAR- apis melifica, aristolochia clematitis, belladonna, chamomilla, lachesis mutus, thuja occidentalis solution/ drops

  • 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 November 13, 2023

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  • Drug Facts

  • Active ingredients & Purposes

    Active Ingredients** (HPUS)Purposes*
    Apis melifica 6C .......................

    Ear pain, inflammation
    Aristolochia clematitis 6C.........Ear inflammation
    Belladonna 6C..........................Throbbing pain
    Chamomilla vulgaris 6C ..........

    Ear pain irritability
    Lachesis mutus 6C ..................Ear inflammation
    Thuja occidentalis 6C ..............Earache from pressure

    The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

  • Uses*

    Temporarily relieves earache symptoms associated with

    • common pain and itching of swimmer's ear
    • clogged ears
    • ear pain or itching from other earaches after diagnosis by a doctor
  • Warnings

    For use in ears only.

    Do not use

    if you have ear tubes, a damaged eardrum, or after surgery

    Stop use and ask your doctor if

    • symptoms persist for more than 48 hours or worsen
    • symptoms are accompanied by a fever
    • any discharge from the ear is present

    If pregnant or breatfeeding,

    seek professional advice before taking this product.

    Keep out of the reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake before use

    adults and children ages 6 and older:

    • tilt head sideways and apply 2-3 drops into the ear (tip of dropper should not enter the ear canal)
    • keep head tilted and allow drops to remain in the ear for 2 minutes or gently place cotton in ear to keep drops in
    • repeat as needed, up to 4 times a day

    children under 6 years of age: do not use

  • Other Information

    • store in a cool dry place
    • do not use if neckband seal is torn, broken, or missing
  • Inactive Ingredients

    glycerin, water

  • Distributed by:

    PHARMADEL LLC.
    New Castle DE, 19720

    +1-866-359-3478

  • Homeopathic Statements

    *These “USES” claims have not been evaluated by the Food and Drug Administration (FDA). They are based on traditional homeopathic practices.

    **C, K, CK and X are homeopathic dilutions.

  • PRINCIPAL DISPLAY PANEL

    Doloear PDP HC

  • INGREDIENTS AND APPEARANCE
    DOLOEAR 
    apis melifica, aristolochia clematitis, belladonna, chamomilla, lachesis mutus, thuja occidentalis solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-327
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_C]  in 15 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_C]  in 15 mL
    ARISTOLOCHIA CLEMATITIS ROOT (UNII: ZY0NX0W00D) (ARISTOLOCHIA CLEMATITIS ROOT - UNII:ZY0NX0W00D) ARISTOLOCHIA CLEMATITIS ROOT6 [hp_C]  in 15 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM6 [hp_C]  in 15 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_C]  in 15 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_C]  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-327-151 in 1 BOX09/07/2023
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/23/2013
    Labeler - Pharmadel LLC (030129680)
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