Label: AURO HOMEOPATHIC EAR RELIEF DROPS- atropa belladonna, oyster shell calcium carbonate, crude, capsicum, matricaria recutita, potassium dichromate, plantago major, and verbascum thapsus liquid

  • NDC Code(s): 63736-326-26
  • Packager: Insight Pharmaceuticals LLC
  • 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 July 2, 2020

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  • SPL UNCLASSIFIED SECTION

    Auro®Earache

    Drug Facts

  • Active ingredients (in each drop)

  • Purpose

    Belladonna 18Xhardness of hearing
    Calcarea carbonica 12Xdiscomfort in ear
    Capsicum annuum 6Xpressure in ear
    Chamomilla 15Xcalmative
    Kali bichromicum 12Xtickling
    Plantago major 4Xsensitivity to discomfort
    Verbascum thapsus 4Xclogging
  • Uses

    may help with the irritation of clogged ears by relieving the sense of discomfort in the ear, sensitivity to earwax and drafts.

  • Warnings

    Do not take by mouth. Ear drops are only to be used in the ears.

    Do not use with ear tubes.

    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

    If pregnant or breast-feeding

    ask a doctor before use.

    Keep out of reach of children.

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

  • Directions

    for adults and children over 6 months of agetilt head sideways and apply 3-4 drops into the affected ear up to 4 times daily. Tip of dropper should not enter ear canal. To keep drops in, tilt ear upward after application or gently place cotton in the ear.
    children under 6 months of ageconsult a doctor
  • Other information

    Do not use if white neck band imprinted with "SEALED FOR YOUR PROTECTION" is broken or missing. Keep carton for full drug facts.

  • Inactive ingredients

    chamomile (flower) extract, citric acid, glycerin, purified water, sodium benzoate

  • Questions?

    call 1-800-344-7239

    Distributed by: INSIGHT Pharmaceuticals, LLC.
    Trevose, PA 19053-8433

  • PRINCIPAL DISPLAY PANEL

    - 29.6 mL Bottle Carton

    Auro®

    Homeopathic*
    Ear
    Relief Drops

    • May help ease symptoms
      of clogged ears
    • Long lasting relief
    • Safe for daily use
    • For children over 6 months

    1FL OZ (29.6 mL)

    PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton Auro® Homeopathic* Ear Relief Drops • May help ease symptoms of clogged ears • Long lasting relief • Safe for daily use • For children over 6 months 1FL OZ (29.6 mL)

  • INGREDIENTS AND APPEARANCE
    AURO HOMEOPATHIC EAR RELIEF DROPS 
    atropa belladonna, oyster shell calcium carbonate, crude, capsicum, matricaria recutita, potassium dichromate, plantago major, and verbascum thapsus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-326
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna18 [hp_X]  in 0.05 mL
    Oyster Shell Calcium Carbonate, Crude (UNII: 2E32821G6I) (Oyster Shell Calcium Carbonate, Crude - UNII:2E32821G6I) Oyster Shell Calcium Carbonate, Crude12 [hp_X]  in 0.05 mL
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum6 [hp_X]  in 0.05 mL
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita15 [hp_X]  in 0.05 mL
    Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate12 [hp_X]  in 0.05 mL
    Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major4 [hp_X]  in 0.05 mL
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus4 [hp_X]  in 0.05 mL
    Inactive Ingredients
    Ingredient NameStrength
    Chamomile (UNII: FGL3685T2X)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-326-261 in 1 CARTON11/15/2013
    129.6 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC11/15/2013
    Labeler - Insight Pharmaceuticals LLC (055665422)
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