Ear Complex (Belladonna, Calcarea Carbonica, Chamomilla, Echinacea Angustifolia, Ferrum Phosphoricum, Hepar Sulphuris Calcareum, Mercurius Solubilis, Pulsatilla) Liquid [Nova Homeopathic Ther -

EAR COMPLEX (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, PULSATILLA) LIQUID [NOVA HOMEOPATHIC THER
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NDC	52731-7008-1, 52731-7008-2
Set ID	b2f6078f-2680-456c-8bd7-0e55e0d002c2
Category	HUMAN OTC DRUG LABEL
Packager	Nova Homeopathic Therapeutics, Inc.
Generic Name
Product Class
Product Number
Application Number

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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.
DOSAGE & ADMINISTRATION

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.
WARNINGS

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
QUESTIONS

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

Ear Complex Product

Ear Complex Bottle Label

Ear Complex Box

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	8 [hp_X] in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X] in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	4 [hp_X] in 1 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	8 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFIDE	8 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	12 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description
Packaging
1	NDC:52731-7008-2	1 in 1 BOX
1	NDC:52731-7008-1	50 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2011

Labeler - Nova Homeopathic Therapeutics, Inc. (194394540)

Registrant - Nova Homeopathic Therapeutics, Inc. (194394540)

Name	Address	ID/FEI	Business Operations
Establishment
Nova Homeopathic Therapeutics, Inc.		194394540	manufacture, label, pack

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Medic

EAR COMPLEX (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, PULSATILLA) LIQUID [NOVA HOMEOPATHIC THER

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