CARBAMIDE PEROXIDE 6.5%- earwax removal kit solution/ drops

Carbamide peroxide 6.5% by

Drug Labeling and Warnings

Carbamide peroxide 6.5% by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Warnings

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

Other information

do not store above 86ºF (30ºC)

protect from heat and direct sunlight

DO NOT USE IF SHRINKBAND ON BOTTLE IS BROKEN OR MISSING

Product foams on contact with earwax due to the release of oxygen. There may be an associated “crackling” sound.

Keep cap on bottle when not in use

Retain carton for full product information.

Inactive ingredients

citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid

Questions/Comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

Earwax label

Earwax carton

INGREDIENTS AND APPEARANCE

CARBAMIDE PEROXIDE 6.5% 
earwax removal kit solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-488
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-488-68	1 in 1 CARTON	10/28/2025
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	10/28/2025

Labeler - Allegiant Health (079501930)