Label: EARACHE DROPS- belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid

  • NDC Code(s): 54973-3172-1, 54973-3172-2
  • Packager: Hyland's Inc.
  • 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 12, 2022

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  • Purpose

    Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ear pain or itching, irritability, minor fever

  • Drug Facts

    Active ingredientsPurpose

    Belladonna 30C HPUS

    (less than 0.000000000001% Alkaloids, calculated)

    		minor fever
    Calcarea Carbonica 30C HPUS
    throbbing ear pain
    Chamomilla 30C HPUS
    occasional sleeplessness and irritability
    Lycopodium 30C HPUSear pain
    Pulsatilla 30C HPUS
    ear itching, pain worse at night
    Sulphur 30C HPUSear pain with burning


    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Uses

    Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician,
    including: ■ ear pain or itching ■ irritability ■ minor fever

  • Warnings

    Keep away from eyes.

    Do not use

    you have ear tubes, damaged ear drums or after ear surgery.

    Stop use and ask a doctor if:

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

    If pregnant or breastfeeding

    ask a health professional before use.

    Keep out of reach of children

  • Directions

    Adults and children ages 2 years and over: ■ Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). ■ Keep head tilted for at least 2 minutes to keep drops in ear. ■ Repeat until relieved, up to 4 times per day. ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.

  • Drug Facts (continued)

    Inactive ingredients

    Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

  • Questions?

    www.hylands.com or (800) 624-9659

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PRINCIPAL DISPLAY PANEL

    Hyland's

    NATURALS

    Earache

    Drops

    RELIEVE EAR

    PAIN FAST*

    Swimmer's Ear

    Cold & Flu

    Allergy

    AGES 2+

    DAY & NIGHT

    0.33 FL. OZ. (10 mL)

    HOMEOPATHIC

    carton

  • INGREDIENTS AND APPEARANCE
    EARACHE DROPS 
    belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3172
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF30 [hp_C]  in 1 mL
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE30 [hp_C]  in 1 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
    ANEMONE PATENS WHOLE (UNII: 4M1169RWJD) (ANEMONE PATENS WHOLE - UNII:4M1169RWJD) ANEMONE PATENS WHOLE30 [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)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3172-11 in 1 CARTON06/17/2004
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:54973-3172-21 in 1 CARTON06/17/200412/28/2021
    212 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/17/2004
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3172) , pack(54973-3172)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources622559110manufacture(54973-3172) , pack(54973-3172)
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