Label: AURO EARACHE RELIEF- matricaria recutita, plantago major, verbascum thapsus, atropa belladonna, chili pepper, oyster shell calcium carbonate, crude, and potassium dichromate liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 23, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Chamomilla (Chamomile)
    1X, 6X, 12X, 30X    		calmative
    Plantago major (Plantain) 4Xpain reliever
    Verbascum thapsus
    (Mullein) 4X    		pain reliever
    Belladonna (Nightshade)
    6X, 12X, 30X    		anti-inflammatory
    Capsicum annuum
    (Cayenne) 6X    		anti-inflammatory
    Calcarea carbonica (Calcium
    carbonate) 12X    		pain reliever
    Kali bichromicum
    (Potassium dichromate) 12X    		pain reliever
  • Uses

    for the temporary relief of pain, discomfort, and irritability associated with earaches in adults and children, after diagnosis by a doctor

  • Warnings

    Do not take by mouth. Earache 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. 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

    citric acid, glycerin, purified water, sodium benzoate

  • Questions

    call 1-800-344-7239

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    INSIGHT Pharmaceuticals Corp.
    Langhorne, PA 19047-1749

  • PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton

    AURO®
    EARACHE RELIEF

    EAR DROPS

    HOMEOPATHIC

    RELIEVES EARACHE PAIN

    • CALMS & SOOTHES
    • SAFE & EFFECTIVE FOR
      ADULTS & CHILDREN

    1 FL OZ (29.6 mL)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    AURO EARACHE RELIEF 
    matricaria recutita, plantago major, verbascum thapsus, atropa belladonna, chili pepper, oyster shell calcium carbonate, crude, and potassium dichromate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-324
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA4 mL  in 30 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR0.3256 mL  in 30 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS0.3256 mL  in 30 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA0.3256 mL  in 30 mL
    CHILI PEPPER (UNII: 00UK7646FG) (CHILI PEPPER - UNII:00UK7646FG) CHILI PEPPER0.3256 mL  in 30 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE0.3256 mL  in 30 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM DICHROMATE0.3256 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorWHITE (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-324-2424 in 1 CASE
    11 in 1 BOX
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic06/01/2010
    Labeler - Insight Pharmaceuticals (176792315)
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