Active Ingredient
Sodium Bicarbonate 5%
Earwax Packaging (Earwax)
Marie Originals Earwax Removal Drops Solution/ Drops
FDA Label NDC 87541-518
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 Marie Originals Earwax Removal Drops (NDC 87541-518). 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 ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Earwax removal aid
Uses
Helps aid in the removal of earwax.
Warnings
Do not use if eardrum is perforated.
For use in the ear only.
Tip of the applicator should never enter the ear canal.
Ask a doctor before use if you have ear drainage or discharge, ear pain, irritation, or rash in the ear.
When using this product avoid contact with the eyes.
Keep out of reach of children.
In case of accidental ingestion, contact a poison control center immediately.
Do not use if the tamper band is broken or missing.
Directions
Tilt head sideways and place 4-5 drops into ear.
Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear.
Use twice daily for up to four days if needed, or as directed by a doctor.
Other Information
Avoid exposing bottle to excessive heat or direct sunlight.
Keep cap on bottle when not in use.
Store at room temperature.
Inactive Ingredients
Purified Water, Citric Acid USP, Isopropyl Alcohol, Vegetable Glycerin USP
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel
Marie Originals
Microfoaming Earwax Removal
Sodium Bicarbonate Drops
0.5 FL OZ (14 mL)
with BioAct-XT and a pH Balancing Formula
Earwax Packaging (Earwax)
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