EAR INFLAMMATION PLUS (belladonna, conium maculatum, dulcamara, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla- vulgaris, liquid

Ear Inflammation Plus by

Drug Labeling and Warnings

Ear Inflammation Plus by is a Homeopathic medication manufactured, distributed, or labeled by Synergy Formulas, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Belladonna 30X, Conium maculatum 30X, Dulcamara 30X, Hepar sulphuris calcareum 30X, Kali bichromicum 30X, Mercurius solubilis 30X, Pulsatilla (Vulgaris) 30X, Silicea 30X, Chamomilla 30C.

INDICAITONS:

For temporary relief of symptoms due to inflammation and pain of the ears.

WARNINGS:

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN: 

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of symptoms due to inflammation and pain of the ears.

INACTIVE INGREDIENTS: 

 Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

SYNERGY FORMULAS, iNC.

251 West Road

Campobello, SC 29322

PACKAGE LABEL DISPLAY: 

Synergy Formulas

EAR INFLAMMATION PLUS

HOMEOPATHIC

2 FL OZ (60 ML)

INGREDIENTS AND APPEARANCE

EAR INFLAMMATION PLUS 
belladonna, conium maculatum, dulcamara, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (vulgaris), liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43772-0032
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30 [hp_X]  in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	30 [hp_X]  in 1 mL
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	30 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	30 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	30 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	30 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43772-0032-1	60 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/13/2014

Labeler - Synergy Formulas, Inc. (069579220)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43772-0032) , api manufacture(43772-0032) , label(43772-0032) , pack(43772-0032)