EARCLEARRX- carbamide peroxide solution/ drops 
Nuance Medical, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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EarClearRx™

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

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

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

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label
EARCLEARRX 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74318-102
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74318-102-0515 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34401/01/2022
Labeler - Nuance Medical, LLC (078797666)

Revised: 11/2021
Document Id: 7de540a2-28f8-41fc-bf5e-289f520fec16
Set id: 8fa15a59-fb7b-4c88-a61d-0cf977a6e834
Version: 1
Effective Time: 20211112
 
Nuance Medical, LLC