EARACHE REMEDY- ear drops liquid

Earache Remedy by

Drug Labeling and Warnings

Earache Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Vitality Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EARACHE REMEDY 
ear drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64616-045
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	6 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_X]  in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	3 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	3 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
WATER (UNII: 059QF0KO0R)
COBALT DISODIUM EDETATE (UNII: 3EY1Y2QRLI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64616-045-02	1 in 1 CARTON	12/09/2005
1	NDC: 64616-045-01	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

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	Business Operations
Vitality Works, Inc.		137752817	manufacture(64616-045)