Active Ingredients:
(in each drop): 10% of Belladonna 30X, Chamomilla 30C, Conium Maculatum 30X, Dulcamara 30X, Ferrum Phosphoricum 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X.
Otoflam Liquid
FDA Label NDC 44911-0513
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Otoflam (NDC 44911-0513). 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:, indications and usage:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications:
May temporarily relieve inflammation and pain of ears.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings:
If pregnant or breast-feeding, ask a health 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.
Directions:
Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 4 days, consult your health care professional. Consult a physician for use in children under 12 years of age.
Indications And Usage:
May temporarily relieve inflammation and pain of ears.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Inactive Ingredients:
Demineralized water, 20% Ethanol.
Questions:
Dist. by Energique, Inc.
201 Apple Blvd
Woodbine, IA 51579
800-869-8078
Package Label Display:
ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
OTOFLAM HP
1 fl. oz. (30 ml)
* Please review the disclaimer below.
