Otc - Active Ingredient
ACTIVE INGREDIENTS: Belladonna 30X, Conium maculatum 30X, Dulcamara 30X, Hepar sulphuris calcareum 30X, Kali bichromicum 30X, Mercurius solubilis 30X, Pulsatilla 30X, Silicea 30X, Chamomilla 30C.
Ear Inflammation Plus
FDA Label NDC 57520-0521
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Ear Inflammation Plus (NDC 57520-0521). 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 otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
INDICATIONS: For temporary relief of symptoms due to inflammation and pain of the ears.
Warnings
WARNINGS: Keep out of 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.
Dosage & Administration
DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Inactive Ingredient
INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol.
Otc - Questions
Distributed by:
SYNERGY FORMULAS, INC.
251 West Road
Campobello, SC 29322
Package Label.Principal Display Panel
Synergy Formulas
EAR INFLAMMATION PLUS
HOMEOPATHIC
2 fl oz (30 ML)
Ear Inflammation Plus (Mm1)
* Please review the disclaimer below.
