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.
Ear Inflammation Plus
FDA Label NDC 43772-0032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Synergy Formulas, Inc. for the product Ear Inflammation Plus (NDC 43772-0032). 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:, indicaitons:, warnings:, keep out of reach of children:, directions:, indications:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
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