Carbamide Peroxide 6.5% Solution/ Drops
FDA Label NDC 69168-488

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Carbamide Peroxide 6.5% (NDC 69168-488). 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(s), purpose, use(s), do not use, when using this product, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Do Not Use

→ When Using This Product

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions/comments

→ Principal Display Panel

Active Ingredient(S)

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Use(S)

For occasional use as an aid to soften, loosen and remove excessive earwax.

Do Not Use

if you have ear drainage or discharge, ear pain, irritation or rash in the ear or are dizzy; consult a doctor
if you have an injury or perforation (hole) in the ear drum or after ear surgery, unless directed by a doctor
for more than 4 days; if excessive earwax remains after use of this product, consult a doctor

When Using This Product

• avoid contact with eyes. If accidental contact with eyes occurs, flush
eyes with water and consult a doctor

Keep Out Of Reach Of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

FOR USE IN EAR ONLY.

Adults and children over 12 years of age: Tilt head sideways and place 5
to 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 the ear. Use twice daily for up to 4 days if
needed, or as directed by a doctor.

• any wax remaining after treatment may be removed by gently
flushing the ear with warm water, using a soft rubber bulb.

Children under 12 years of age: consult a doctor