Label: HYLANDS NATURALS EARACHE DROPS- belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,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 July 27, 2023

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  • Drug Facts

    Active ingredientsPurpose*
    Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated)ear pain
    Calcarea Carbonica 30C HPUSear pain, sensitivity to cold
    Chamomilla 30C HPUSear pain, sensitivity to
    drafts, plugged ears
    Lycopodium 30C HPUSear pain
    Pulsatilla 30C HPUSear itching
    Sulphur 30C HPUSear pain with burning,
    sensitivity to water

    HPUS" is the Homeopathic Pharmacopoeia of the
    United States.

  • Uses*

    Temporarily relieves:
    ■ common pain or itching from swimmer’s ear
    ■ clogged ears
    ■ ear pain or itching from other earaches,
    after diagnosis by a physician

  • Warnings

    Keep away from eyes.

    Do not use if 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.

  • Drug Facts (continued)

    Directions

    Adults and children ages
    4 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.

  • Inactive ingredients

    Citric Acid, Glycerine, Purified Water.

  • Questions?

    www.hylands.com
    or care@hylands.com

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

  • OTHER SAFETY INFORMATION

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

  • PURPOSE

    Temporarily relieves: common pain or itching from swimmer’s ear, clogged ears, ear pain or itching from other earaches, after diagnosis by a physician

  • Principal Display Panel

    Hyland's Naturals

    Earache Drops 0.33 FL. OZ. (10 mL)

    carton

    label

  • INGREDIENTS AND APPEARANCE
    HYLANDS NATURALS EARACHE DROPS 
    belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4124
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE30 [hp_C]  in 1 mL
    BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF30 [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
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4124-11 in 1 CARTON07/27/2023
    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 homeopathic07/27/2023
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-4124) , pack(54973-4124) , label(54973-4124)
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