Otc - Active Ingredient
Lidocaine HCl 4%
Earbalance Ear Pain Drops Solution/ Drops
FDA Label NDC 87541-498
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 87541-498). 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, stop use and ask a doctor if, 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-irritation soreness.
Warnings
For use in the ear canal only.
Do Not Use
if your child has a damaged eardrum
if your child has ear tubes
if allergic to lidocaine or any ingredient in this product
When Using This Product
avoid contact with eyes
do not swallow
temporary numbness may occur
Ask A Doctor Before Use If
ear drainage, bleeding, fever, hearing loss, dizziness, ringing in the ears, or severe ear pain is present
Stop Use And Ask A Doctor If
symptoms worsen or last longer than 48 hours
rash or irritation develops
Keep Out Of Reach Of Children
If swallowed, contact a Poison Control Center right away.
Directions
Ages 6-12: 3-5 drops up to 4 times daily
Ages 2-5: 2-3 drops up to 3 times daily
Keep head tilted 2-3 minutes
Do not use longer than 4 days unless directed by a doctor
Under 2 years: ask a doctor
Inactive Ingredients
Alcohol, Acetum (Apple Cider Vinegar), Echinacea Purpurea Extract, Hydrastis Canadensis Root Extract
Other Information
Store at 20° to 25°C (68° to 77°F)
Protect from light
Keep tightly closed
Do not use if seal is broken
Questions Or Comments?
Call 1-888-48-MARIE
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.
