EAR- baptisia tinctoria, echinacea, hydrastis canadensis, phytolacca decandra, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla, liquid
Apotheca Company

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.

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Ear

Active Ingredients: Baptisia Tinctoria 3X, Echinacea 3X, Hydrastis Canadensis 3X, Phytolacca Decandra 3X, Capsicum Annuum 12X, Chamomilla 12X, Ferrum Phosphoricum 12X, Kali Muriaticum 12X, Plantago Major 12X, Pulsatilla 12X.

Indications: For temporary relief of mild earache with soreness, sticking pain in ears, and minor swelling of the ear with redness.

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

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

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

Store in a cool, dry place.

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.

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

Indications:

For temporary relief of mild earache with soreness, sticking pain in ears, and minor swelling of the ear with redness.

Other Ingredients: Demineralized Water, 25% Ethanol

Distributed By: BioActive Nutritional

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 92935

Ear BioActive Homeopathic

EAR

1 FL OZ (30 ML)

EAR
baptisia tinctoria, echinacea, hydrastis canadensis, phytolacca decandra, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0088
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	12 [hp_X] in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	12 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_X] in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	12 [hp_X] in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X] in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	12 [hp_X] in 1 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	12 [hp_X] 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:57520-0088-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/15/2010	03/28/2017

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0088) , api manufacture(57520-0088) , label(57520-0088) , pack(57520-0088)

Revised: 6/2015

Document Id: 2bee35dd-0224-4d3b-8d54-f687a2b44c2e

Set id: 7c8f6c45-0390-447e-a549-34fd6b427ead

Version: 3

Effective Time: 20150617

Apotheca Company