Ear Inflammation Plus: Homeopathic Product Information

EAR INFLAMMATION PLUS- atropa belladonna, conium maculatum flowering top, solanum dulcamara top, calcium sulfide, potassium dichromate, mercurius solubilis, pulsatilla vulgaris, silicon dioxide and matricaria recutita liquid
Synergy Formulas, 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.

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)

Ear Inflammation Plus
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 30 [hp_X] in 1 mL
CONIUM MACULATUM FLOWERING TOP (CONIUM MACULATUM FLOWERING TOP) CONIUM MACULATUM FLOWERING TOP 30 [hp_X] in 1 mL
SOLANUM DULCAMARA TOP (SOLANUM DULCAMARA TOP) SOLANUM DULCAMARA TOP 30 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 30 [hp_X] in 1 mL
POTASSIUM DICHROMATE (DICHROMATE ION) POTASSIUM DICHROMATE 30 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 30 [hp_X] in 1 mL
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 30 [hp_X] in 1 mL
SILICON DIOXIDE (COLLOIDAL SILICON DIOXIDE) SILICON DIOXIDE 30 [hp_X] in 1 mL
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 30 [hp_C] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43772-0032-1 60 mL in 1 BOTTLE, DROPPER None
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 Operations
Apotheca Company 844330915 manufacture (43772-0032), api manufacture (43772-0032), label (43772-0032), pack (43772-0032)

Revised: 05/2014 Synergy Formulas, Inc.

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