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

  • 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 28, 2022

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  • PURPOSE

    ■ Temporarily relieves symptoms of earache in children after diagnosis by a physician, including:
    ■ minor fever ■ ear pain or throbbing
    ■ irritability ■ occasional sleeplessness
    ■ common pain or itching of "swimmer’s ear"

  • Drug Facts

    Active ingredientsPurpose

    Belladonna 30C HPUS

    (less than 0.0000000000001 % Alkaloids, calculated)

    		fever
    Calcarea Carbonica 30C HPUSthrobbing ear pain
    Chamomilla 30C HPUSoccasional sleeplessness and irritability
    Lycopodium 30C HPUSear pain
    Pulsatilla 30C HPUSear itching, pain worse at night
    Sulphur 30C HPUSear pain with burning

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

  • Uses

    ■ Temporarily relieves symptoms of earache in children after diagnosis by a physician, including:
    ■ minor fever ■ ear pain or throbbing
    ■ irritability ■ occasional sleeplessness
    ■ common pain or itching of "swimmer’s ear"

  • Warnings

    Keep away from eyes. Do not take by mouth. Earache drops are only to be used in the ears.

    Do not use if you have ear tubes, damaged ear drums or after ear surgery.

    Consult a physician if:
    ■ symptoms persist for more than 48 hours or worsen.
    ■ discharge from ear is present.
    ■ symptoms are accompanied by a high fever (over 101°F).

    Keep this and all medications out of the reach of children.

    If swallowed contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    ■Shake well before using.

    Children under
    6 months     		Consult a physician.
    Children 6 months
    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 daily.

  • Drug Facts (continued)

    Other information

    ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
    ■ Store at room temperature.
    ■ Do not refrigerate.

  • Inactive ingredients

    Citric Acid,Glycerine, Purified Water, Sodium Benzoate.

  • Questions or comments?

    (800) 624-9659

  • SPL UNCLASSIFIED SECTION

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

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC

    NDC 54973-7516-3

    6+

    months

    NEW

    LOOK

    BABY

    SINCE 1903
    Hyland's

    Infant
    Earache Drops*


    Relieves earache due to cold, flu,
    allergy and swimmer's ear


    NO DYES or PARABENS
    NO NUMBING EFFECT


    Natural
    Relief

    0.33 FL.OZ. (10mL)


    *SEE NOTE ON SIDE
    PANEL BELOW DRUG FACTS

    Carton

  • INGREDIENTS AND APPEARANCE
    BABY INFANT EARACHE DROPS 
    belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-7516
    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
    PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA 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:54973-7516-31 in 1 CARTON03/16/2004
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/16/2004
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-7516) , pack(54973-7516)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources622559110manufacture(54973-7516) , pack(54973-7516)
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