EARACHE (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SULPHUR) LIQUID [CVS PHARMACY]

EARACHE (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SULPHUR) LIQUID [CVS PHARMACY]
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NDC 59779-568-15
Set ID e9767a0e-3456-4805-9169-35852cfe5bb3
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENTS:

    Belladonna 30C HPUS.........................Temperature above normal

    Calcarea Carbonica 30C HPUS.............Burning Ear

    Chamomilla 30C HPUS.......................Sleeplessness and irritability

    Lycopodium Clavatum 30C HPUS.......Ear discomfort

    Pulsatilla (Vulgaris) 30C HPUS............Ear itching, discomfort at night

    Sulphur 30C HPUS............................Throbbing ear

    The letter HPUS indicate that the components of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • USES*:

    •For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of temperature above normal, discomfort, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common discomfort and itching of "swimmer's ear". *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS:

    USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.

    Keep away from the eyes. 

    • This product is intended to complement, not replace standard medical treatment. • Initial worsening of the symptoms may occur. 

    • A physician should always be consulted to rule out serious causes. 

    • If pregnant or breast-feeding, ask a health professional before use. 

     Keep out of the reach of children. 

    • If swallowed, get medical help or contact a Poison Control Center right away.

    Do not use

    • If you have ear drainage, irritation, discharge or rash in the ear, consult a physician.

    • With ear tubes, damaged ear drums or after surgery.

    • If drops become cloudy.

     Stop use and ask a doctor if

    • Symptoms worsen or continue for more than 48 hours.

    • There is discharge from the ear.

    • A fever greater than 102°F is present.

  • OTHER SAFETY INFORMATION:

    Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.

    • Store at 15°C-30°C (59°F-86°F).

    • Protect from light and excessive moisture.

    †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • DO NOT USE:

    DO NOT USE IF INPRINTED SEAL ON CAP IS TORN, BROKEN OR MISSING.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Suitable for adults and children over the age of 2.

    • For use in the ears only.

    • Remove any hearing aids before using this product.

    • Use 3 to 5 drops twice per day or as needed.

    • Warm contents to body temperature by holding bottle in your hands.

    • Tilt your head to the side and let solution drip into the ear. Never put the tip into the ear canal.

    • Keep drops in your ear by tilting your head for 1-2 minutes or gently place cotton in the ear to keep drops in.

  • INDICATIONS:

    •For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of temperature above normal, discomfort, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common discomfort and itching of "swimmer's ear". *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    benzalkonium chloride, citric acid, glycerin, purified water

  • QUESTIONS:

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    ©2020 CVS/Pharmacy

    CVS.com

    1-800-SHOP CVS

    V-19655

  • PACKAGE LABEL DISPLAY:

    CVS

    Health

    Compare to the

    active ingredients in

    Hyland's® Earache Drops

    NDC 59779-568-15

    Homeopathic

    EarAche

    EAR DROPS

    • Relieves discomfort,

       calms irritability*

    • Soothes itching due to

       cold, swimmer's ear

    & allergy*

    Package Contains 

    One Bottle

    0.33 FL OZ (10mL)

    Earache LBL

    Earache CTN

  • INGREDIENTS AND APPEARANCE
    EARACHE 
    belladonna, calcarea carbonica, chamomilla, lycopodium clavatum, pulsatilla (vulgaris), sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-568
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_C]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-568-1510 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/22/2016
    Labeler - CVS Pharmacy (062312574)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(59779-568) , api manufacture(59779-568) , label(59779-568) , pack(59779-568)

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