FDA Label for Waxrx Ear Wax Removal Aid Drops

Otc - Active Ingredient

Carbamide Peroxide 6.5%

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)