Earache Remedy: Homeopathic Product Information

EARACHE REMEDY- aconitum napellus, atropa belladonna, potassium chloride, plantago major, matricaria recutita and verbascum thapsus liquid
Vitality Works, Inc.

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.

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.

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

Label
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Carton
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EARACHE REMEDY
ear drops liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64616-045
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 6 [hp_X] in 1 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 3 [hp_X] in 1 mL
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 3 [hp_X] in 1 mL
PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 3 [hp_X] in 1 mL
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 6 [hp_X] in 1 mL
VERBASCUM THAPSUS (VERBASCUM THAPSUS) VERBASCUM THAPSUS 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
OLEA EUROPAEA LEAF
WATER
COBALT DISODIUM EDETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64616-045-02 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER (64616-045-01)
1 NDC:64616-045-01 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (64616-045-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/23/2004
Labeler — Vitality Works, Inc. (137752817)
Registrant — Vitality Works, Inc. (137752817)
Establishment
Name Address ID/FEI Operations
Vitality Works, Inc. 137752817 manufacture (64616-045)

Revised: 12/2020 Vitality Works, Inc.

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