The following Structured Product Label (SPL) was submitted to the FDA by Bioactive Nutritional, Inc. for the product Ear (NDC 43857-0539). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
For temporary relief of mild earache with soreness, sticking pain in ears, and minor swelling of the ear with redness.
For temporary relief of mild earache with soreness, sticking pain in ears, and minor swelling of the ear with redness.
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. In case of overdose, get medical help or contact a Poison Control Center right away.
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Demineralized Water, 25% Ethanol
Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com
BIOActive Nutritional
EAR
HOMEOPATHIC
1 FL OZ (30 ml)
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