FRESKARO EARWAX REMOVAL AID- carbamide peroxide 6.50% kit liquid

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

PURPOSE

Earwax removal aid

INDICATIONS & USAGE

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) of the ear or after ear surgery, unless directed by a doctor
• for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.

When using this product

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

Stop use and ask a doctor if

• excessive earwax remains after use of this product for 4 consecutive days.

INACTIVE INGREDIENT

Citric acid

Flavor

Glycerin

Propylene Glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified Water

DOSAGE & ADMINISTRATION

• FOR USE IN THE EAR ONLY. Remove any hearing aids before use.
• Adults and children over 12 years of age:
• ​tilt head sideways
• 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 four days if needed, or as directed by a doctor
• any wax remaining after treatment may be removed by gently flushing ear with warm (body temperature) water, using a soft rubber bulb ear syringe
• Children under 12 years of age: Consult a physician

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Posion Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESKARO EARWAX REMOVAL AID 
carbamide peroxide 6.50% kit liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-097
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	6.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM STANNATE (UNII: NJ7C1V83KG)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82645-097-90	1 in 1 CARTON	04/13/2026
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	04/13/2026

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	pack(82645-097) , label(82645-097) , manufacture(82645-097) , analysis(82645-097)