Ear Complex: Homeopathic Product Information

EAR COMPLEX — atropa belladonna, oyster shell calcium carbonate, crude, matricaria recutita, echinacea angustifolia, ferrum phosphoricum, calcium sulfide, mercurius solubilis and pulsatilla vulgaris liquid
Nova Homeopathic Therapeutics, 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.

Purpose:

Suggested use for one or more of the following symptoms:

Earache with deep throbbing pain,stopped up and sore ears

Usage and Dosage:

For oral use only.

Adults:
In Acute Phase:
12-15 drops, every half hour until relief occurs
When Relief Occurs:
12-15 drops, 4-6 times per day
Children 2-12 years:
8-10 drops, 4-6 times per day
Infants 0-24 months:
4 drops, 4-6 times per day

Warnings:

Keep out of reach of children.

If symptoms persist, consult a physician.
Do not use if ring on bottom of cap is broken or missing.

Active Ingredients:

Belladonna 6X, Calcarea carbonica 8X, Chamomilla 6X, Echinacea angustifolia 4X, Ferrum phosphoricum 8X, Hepar sulphuris calcareum 12X, Mercurius solubilis 8X, Pulsatilla 6X

Inactive Ingredients:

Alcohol, 20% USP

Manufactured by Nova Homeopathic Therapeutics Inc., Albuquerque, New Mexico USA 87109
1-800-225-8094

Ear Complex Product

Ear Complex Product
(click image for full-size original)

Ear Complex Bottle Label

Ear Complex Bottle
(click image for full-size original)

Ear Complex Box

Ear Complex Box
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EAR COMPLEX
belladonna, calcarea carbonica, chamomilla, echinacea angustifolia, ferrum phosphoricum, hepar sulphuris calcareum, mercurius solubilis, pulsatilla liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52731-7008
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 6 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 8 [hp_X] in 1 mL
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 6 [hp_X] in 1 mL
ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA) ECHINACEA ANGUSTIFOLIA 4 [hp_X] in 1 mL
FERRUM PHOSPHORICUM (FERRUM PHOSPHORICUM) FERRUM PHOSPHORICUM 8 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM CATION) CALCIUM SULFIDE 8 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 12 [hp_X] in 1 mL
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52731-7008-2 1 BOTTLE (BOTTLE) in 1 BOX contains a BOTTLE (52731-7008-1)
1 NDC:52731-7008-1 50 mL in 1 BOTTLE This package is contained within the BOX (52731-7008-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 06/01/2011
Labeler — Nova Homeopathic Therapeutics, Inc. (194394540)
Registrant — Nova Homeopathic Therapeutics, Inc. (194394540)
Establishment
Name Address ID/FEI Operations
Nova Homeopathic Therapeutics, Inc. 194394540 manufacture, label, pack

Revised: 06/2011 Nova Homeopathic Therapeutics, Inc.

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