Ear: Homeopathic Product Information

EAR- baptisia tinctoria root, echinacea angustifolia, phytolacca americana root, goldenseal, capsicum, matricaria recutita, ferrosoferric phosphate, potassium chloride, plantago major and anemone pratensis liquid
BioActive Nutritional, 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:

Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Phytolacca Decandra 3X, Hydrastis Canadensis 5X, Capsicum Annuum 12X, Chamomilla 12X, Ferrum Phosphoricum 12X, Kali Muriaticum 12X, Plantago Major 12X, Pulsatilla (Pratensis) 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 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.

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

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional
EAR
HOMEOPATHIC
1 FL OZ (30 ml)

Ear
(click image for full-size original)
EAR
baptisia tinctoria, echinacea (angustifolia), phytolacca decandra, hydrastis canadensis, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla (pratensis) liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0539
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BAPTISIA TINCTORIA ROOT (BAPTISIA TINCTORIA ROOT) BAPTISIA TINCTORIA ROOT 3 [hp_X] in 1 mL
ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA) ECHINACEA ANGUSTIFOLIA 3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT) PHYTOLACCA AMERICANA ROOT 4 [hp_X] in 1 mL
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 5 [hp_X] in 1 mL
CAPSICUM (CAPSICUM) CAPSICUM 12 [hp_X] in 1 mL
MATRICARIA RECUTITA (MATRICARIA CHAMOMILLA) MATRICARIA RECUTITA 12 [hp_X] in 1 mL
FERROSOFERRIC PHOSPHATE (FERROSOFERRIC PHOSPHATE) FERROSOFERRIC PHOSPHATE 12 [hp_X] in 1 mL
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CATION 12 [hp_X] in 1 mL
PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 12 [hp_X] in 1 mL
ANEMONE PRATENSIS (ANEMONE PRATENSIS) ANEMONE PRATENSIS 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43857-0539-1 30 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/24/2019
Labeler — BioActive Nutritional, Inc. (624980496)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (43857-0539), api manufacture (43857-0539), label (43857-0539), pack (43857-0539)

Revised: 10/2019 BioActive Nutritional, Inc.

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