Otc - Active Ingredient
Lidocaine HCl 4%
Earbalance Ear Pain Drops Solution/ Drops
FDA Label NDC 87541-896
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marie's Original Formulas Llc for the product Earbalance Ear Pain Drops (NDC 87541-896). 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, purpose, uses, warnings, do not use, when using this product, ask a doctor before use if you have, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local anesthetic
Uses
Temporarily relieves ear discomfort and minor pain associated with swimmer's ear, ear canal irritation, and post-irrigation soreness.
Warnings
For use in the ear canal only.
Do Not Use
if the eardrum is perforated or ruptured
if you have ear tubes
if you are allergic to lidocaine or any ingredient in this product
When Using This Product
use only in the ear canal
avoid contact with eyes
do not swallow
temporary numbness may occur
Ask A Doctor Before Use If You Have
ear drainage, discharge, bleeding, fever, sudden hearing loss, dizziness, or ringing in the ears
Stop Use And Ask A Doctor
pain worsens or lasts longer than 48 hours
irritation, redness, or allergic reaction occurs
symptoms occur with fever or discharge
If Pregnant Or Breast-Feeding
ask a health professional before use
Keep Out Of Reach Of Children
If swallowed, contact a Poison Control Center right away at 1-800-222-1222.
Directions
Adults and children 6 years and older: place 3 to 5 drops into affected ear up to 4 times daily.
Keep head tilted for 2 to 3 minutes after application.
Children under 6 years: ask a doctor.
Inactive Ingredients
Alcohol USP, Organic Apple Cider Vinegar, Echinacea (Echinacea purpurea) Extract, Goldenseal (Hydrastis canadensis) Root Extract.
Principal Display Panel
EarBalance by Marie Originals
Ear Pain Drops
Kids
Ear Pain Relief
With 4% Lidocaine HCl + Botanical Extracts
Fast-Acting Relief
pH-Balanced Ingredients
Gentle for Kids' Ears
Net 0.5 fl oz (14 mL)
* Please review the disclaimer below.
