EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]

EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]
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NDC 64616-045-01, 64616-045-02
Set ID 49afb2c3-ee42-4be9-943a-36d73ded0004
Category HUMAN OTC DRUG LABEL
Packager Vitality Works, Inc.
Generic Name
Product Class
Product Number
Application Number
  • Earache Remedy


    Aconitum napellus 6X

    Belladonna 3X

    Chamomilla 6X

    Kali mur 3X

    Plantago major 3X

    Verbascum 6X

  • Earache Remedy

    Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water

  • Earache Remedy

    Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing seek the advice of your health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accedental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but this is not intended for internal use.

  • Earache Remedy

    Keep this and all medicines out of reach of children.

  • Earache Remedy

    A homeopathic combination for the temporary relief or earaches, inflammation of the external and internal ear. For the temporary relief of earches from congestion or swelling of middle ear or eustacian tubes.

  • DOSAGE & ADMINISTRATION

    Warm up bottle by gently rolling it between your hands before use. Tilt head sideways and place 2 to 3 drops into ear. Tip of applicator should not enter ear canal. Repeat 2-3 times/day for up to 4 days, if needed, or as directed by your health care professional.

  • Earache Remedy

    Aconitum napellus - relieves earache, hot, painful, swollen ear.

    Belladonna - relieves Otitis media, throbbing deep ear pain.

    Chamomilla - relieves eache, soreness, swelling, otalgia.

    Kali mur - relieves chronic catarrahal conditions of middle ear.

    Plantago major - relieves earache, neuralgic earache, otalgia.

    Verbascum - relieves catarrhs, otalgia with sense of obstruction.

  • Earache Remedy

    LabelCarton

  • INGREDIENTS AND APPEARANCE
    EARACHE REMEDY 
    ear drops liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-045
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 1 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE3 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR3 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 1 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    WATER (UNII: 059QF0KO0R)  
    COBALT DISODIUM EDETATE (UNII: 3EY1Y2QRLI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-045-021 in 1 CARTON12/09/2005
    1NDC:64616-045-0115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/23/2004
    Labeler - Vitality Works, Inc. (137752817)
    Registrant - Vitality Works, Inc. (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817manufacture(64616-045)

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