Ear Inflammation Plus (Belladonna, Conium Maculatum, Dulcamara, Hepar Sulphuris Calcareum, Kali Bichromicum, Mercurius Solubilis, Pulsatilla (Vulgaris),) Liquid [Synergy Formulas, Inc.] -

EAR INFLAMMATION PLUS (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS),) LIQUID [SYNERGY FORMULAS, INC.]
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NDC	43772-0032-1
Set ID	f6dd4fd3-b19b-46c6-93a5-881227c2facb
Category	HUMAN OTC DRUG LABEL
Packager	Synergy Formulas, Inc.
Generic Name
Product Class
Product Number
Application Number

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

Labeler - Synergy Formulas, Inc. (069579220)

Registrant - Apotheca Company (844330915)

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

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Medic

EAR INFLAMMATION PLUS (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS),) LIQUID [SYNERGY FORMULAS, INC.]

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