EARCLEARRX- carbamide peroxide solution/ drops

EarClearRx by

Drug Labeling and Warnings

EarClearRx by is a Otc medication manufactured, distributed, or labeled by Nuance Medical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Carbamide Peroxide USP 6.5%

USES

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

WARNINGS

Ask a doctor before use if you have ear drainage, discharge, ear pain, irritation or rash in the ear, dizziness, had an injury or perforation of the ear drum. When using this product avoid contact with the eyes. Stop use and ask a doctor if you need to use for more than four days.

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222).

DIRECTIONS

FOR USE IN THE EAR ONLY. Tilt head sideways, place 5-10 drops in the ear, tip of the applicator should not enter the ear canal. Keep drops in the 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 the ear with warm water, using an ear irrigation system.

INACTIVE INGREDIENTS

Glycerin, Propylene Glycol, Sodium Bicarbonate, Lactic Acid, Purified Water

SPL UNCLASSIFIED SECTION

Children under 12 years of age: consult a doctor before use.

Other information

Do not store above 25°C (77°F).

Question or Comments

(760) 362-8411

SPL UNCLASSIFIED SECTION

Distributed by: Nuance Medical LLC

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

EARCLEAR Rx™

EAR WAX
REMOVAL
DROPS

Active ingredients:
Carbamide Peroxide USP 6.5%

0.5 FL OZ (15 mL)
NDC: 74318-102-05

INGREDIENTS AND APPEARANCE

EARCLEARRX 
carbamide peroxide solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74318-102
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
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74318-102-05	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	01/01/2022

Labeler - Nuance Medical, LLC (078797666)