Otc - Active Ingredient
Carbamide Peroxide 6.5%
Waxrx Ear Wax Removal Aid Drops Liquid
FDA Label NDC 72724-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Doctor Easy Medical Products, Llc for the product Waxrx Ear Wax Removal Aid Drops (NDC 72724-001). 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, indications & usage, warnings, otc - stop use, otc - when using, otc - keep out of reach of children, for use in the ear only, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Carbamide Peroxide 6.5%...................Earwax Removal Aid
Indications & Usage
For occasional use as an aid to soften, loosen and remove excessive ear wax
Warnings
Ask a doctor before use if you have
• ear drainage or discharge
• ear pain
• irritation or rash in the ear
• dizziness
• an injury or perforation (hole) of the ear drum
• recently had ear surgery
Otc - Stop Use
Stop use and ask a doctor if
• you need to use for more than 4 days
• excessive ear wax remains after use of this product
Otc - When Using
When using this product do not get into eyes
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose or allergic
reaction, get medical help or contact a Posion Control Center immediately
For Use In The Ear Only
Adults and children over 12 years of age. Tilt head sideways and place 5-10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in ears. Flush ear with VERY WARM (body temperature) water using the Wax-Rx Ear Washer.
Children under 12, consult a physician. Drops my be used twice daily for up to 4 days or as directed by a physician.
Storage And Handling
• Avoid exposing bottle to excessive heat or direct sunlight.
• Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling
• Keep cap on bottle when not in use.
• Lot no. and exp. date:see Label, bottom contained or box.
Inactive Ingredient
Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid
Package Label.Principal Display Panel
WaxRx
EAR WAX
REMOVAL
AID DROPS
6.5% Carbamide Peroxide
Safe, Fast Acting
Alcohol Free
0.5 FL OZ (15 ML)
* Please review the disclaimer below.
