PEDIATRIC EARACHE REMEDY- ear drops liquid

Pediatric Earache Remedy by

Drug Labeling and Warnings

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

Drug Details [pdf]

Pediatric Earache Remedy

Aconitum napellus 6X

Belladonna 3X

Chamonilla 6X

Kali mur 3X

Plantago major 3X

Verbascum 6X

Pediatric Earache Remedy

Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water

Pediatric 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 you 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 accidental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but they are not intended for internal use.

Pediatric Earache Remedy

Keep this and all medicines out reach of children.

Pediatric Earache Remedy

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

Pediatric Earache Remedy

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.

Pediatric Earache Remedy

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

Belladonna - relieves otitis media, throbbing deep ear pain.

Chamomilla - relieves earache, 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.

Pediatric Earache Remedy

INGREDIENTS AND APPEARANCE

PEDIATRIC EARACHE REMEDY 
ear drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64616-050
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
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
WATER (UNII: 059QF0KO0R)
COBALT DISODIUM EDETATE (UNII: 3EY1Y2QRLI)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64616-050-02	1 in 1 CARTON	07/30/2007
1	NDC: 64616-050-01	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		10/23/2006

Labeler - Vitality Works, Inc (137752817)

Registrant - Vitality Works, Inc. (137752817)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works, Inc.		137752817	manufacture(64616-050)