Label: DOLOEAR- atropa belladonna, apis mellifera, aristolochia clematitis root, matricaria recutita, lachesis muta venom, and thuja occidentalis leafy twig 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 December 1, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients HPUS:Purpose
    Belladonna 6CPain in ears, inflammation
    Apis mellifica 6CPain in ears, inflammation
    Aristolochia clematis 6CEar pain with tinnitus
    Chamomilla 6CEarache, toothache
    Lachesis mutus 6CEar pain with wax build up
    Thuja occidentalis 6COtalgia with noises in ears
  • Uses

    For the temporary relief of earache associated with cold and flu, sore throat, swimmer's ear, sinusitis or wax build up.

  • Warnings

    For use in ears only.

    Do not use if you have: ear drainage, discharge, dizziness, ear tubes, damaged ear drum, or fever of 102 or greater.

    Consult a physician before use: if pregnant or breastfeeding, in children under 2 years of age.

    Stop use and ask your doctor: if symptoms worsen, reoccur, or persist for more than 48 hours, or if fever develops.

    Keep out of the reach of children

    Do not use if neckband is missing or broken

  • Directions

    Adults and children: Remove tamper-evident neckband from bottle. Shake bottle before each use. Tilt head sideways and apply 2-3 drops into ear (to preserve purity, prevent tip of dropper from touching ear.) Allow drops to remain in ear by keeping head tilted or placing cotton in ear. Repeat as needed.

  • Inactive Ingredients

    Glycerin USP, DI water.

  • Questions, Comments?

    call 1-866-359-3478 M-F 9 AM to 5 PM Eastern Time

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    PHARMADEL LLC. ®
    Seaford, DE 19973

  • PRINCIPAL DISPLAY PANEL - 15mL Bottle Label

    DoloEar™

    Homeopathic Ear Drops

    For the temporary relief of:
    earache associated
    with cold and flu,
    sore throat,
    swimmer's ear,
    sinusitis or
    wax build up.

    0.50 FL OZ (15mL)

    PRINCIPAL DISPLAY PANEL - 15mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOLOEAR 
    atropa belladonna, apis mellifera, aristolochia clematitis root, matricaria recutita, lachesis muta venom, and thuja occidentalis leafy twig solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-001
    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
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [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
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-001-1515 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/23/2013
    Labeler - Pharmadel LLC (030129680)
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