EARACHE DROPS (ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, AND SULFUR) LIQUID [WAL-MART STORES, INC]

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  • EARACHE DROPS (ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, AND SULFUR) LIQUID [WAL-MART STORES, INC]

EARACHE DROPS (ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, AND SULFUR) LIQUID [WAL-MART STORES, INC]
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NDC 49035-320-01
Set ID 1cf1d27a-5fd0-4304-9748-ef36f75099e5
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores, Inc
Generic Name
Product Class
Product Number
Application Number
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  • PURPOSE

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

  • Drug Facts

    Active ingredientsPurpose

    Belladonna 30C HPUS

    (less than 0.0000000000001% Alkaloids)

    		minor 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 after diagnosis by a physician, including: ■ minor fever ■ ear pain or throobing ■ 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 ears.

    As with any drug, ask a doctor before use ii pregnant or breast-reeding.

    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 wcraen.
    ■ discharge from ear is present.
    ■ symptoms are accompanied by a fever (over 101'F).

  • Drug Facts (continued)

    Keep this and all medications out of the reach of children. If swallowed, contact a medical professional or Poison Control Center (1-800-222-1222) right away.

  • Directions

    ■ Shake well before using.

    Adults and children ages 2 years and over: TIit 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.

  • 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 nol refrigerate.

  • Inactive Ingredients

    Citric Acid, Glycerin, Purified Water, Sodium Benzoate.

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL

    HOMEOPATHIC PRACTICE, NOT ACCEPTED

    MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • Questions or comments?

    Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Wal-Mart Inc.,

    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    NDC 49035-320-01

    equate™

    Compare
    to Hyland's
    Earache
    Drops

    active

    ingredients

    Homeopathic

    Earache
    Drops*

    • Relieves ear pain
    • Calms irritability
    • Soothes itching due to cold & flu, swimmer's ear

    & allergies

    0.33 FL OZ (10mL)

    *CLAIMS BASED ON TRADITIONAL

    HOMEOPATHIC PRACTICE, NOT ACCEPTED

    MEDICAL EVIDENCE. NOT FDA EVALUATED.

    carton

  • INGREDIENTS AND APPEARANCE
    EARACHE DROPS 
    atropa belladonna, oyster shell calcium carbonate, crude, matricaria recutita, lycopodium clavatum spore, pulsatilla vulgaris, and sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-320
    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) (PULSATILLA VULGARIS - 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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-320-011 in 1 CARTON02/25/2015
    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 homeopathic02/25/2015
    Labeler - Wal-Mart Stores, Inc (051957769)
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