EAR WAX REMOVAL- carbamide peroxide liquid
Starkey Hearing Technologies

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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Ear Wax Removal Drops Carton

Drug Facts

Active ingredient

Carbamide peroxide 6.5%

Purpose

Ear wax removal product

Uses

For occasional use as an aid to soften, loosen and remove excessive ear wax

Warnings

For use in the ear only

Do not use:

If you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; ask a doctor
If you have an injury or perforation (hole) of the eardrum or after ear surgery unless directed by a doctor
For more than 4 days

When using this product avoid contact with the eyes.

Stop use and ask a doctor if excessive ear wax remains after use of this product for 4 consecutive days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

Directions

FOR USE IN THE 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 or ear syringe (not included)
- When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal
Children under 12 years of age: Ask a doctor

Other information

Store at 20-25°C (68-77'F)
Protect from heat or direct sunlight
Keep cap tightly on bottle when not in use
Product foams on contact with ear wax due to release of oxygen. There may be an associated “crackling" sound.

Inactive Ingredients

Glycerin, propylene glycol, peppermint flavor, citric acid, sodium lauroyl sarcosinate

Tamper Evident. Do not use if neckband on bottle is broken or missing.

Questions or comments?

877-373-4034

Distributed by

Starkey Hearing Technologies

Eden Prairie, MN 55344

earhealth.starkey.com

Technologies .

Made in USA

Principal Display Panel – 15 mL Carton Label

Starkey®
Hearing Technologies

Ear Wax
Removal Drops

Carbamide peroxide
ear was removal aid

Safe and gentle use
Fast-acting formula
Easily cleanses ear with microfoam action

Safe for all ages

AUDIOLOGIST RECOMMENDED

.5 FL OZ (15 mL)

Principal Display Panel – 15 mL Carton Label

EAR WAX REMOVAL
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70903-200
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Carbamide Peroxide (UNII: 31PZ2VAU81) (Hydrogen Peroxide - UNII:BBX060AN9V)	Carbamide Peroxide	6.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Glycerin (UNII: PDC6A3C0OX)
Propylene glycol (UNII: 6DC9Q167V3)
Peppermint (UNII: V95R5KMY2B)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium lauroyl sarcosinate (UNII: 632GS99618)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70903-200-15	1 in 1 BOX	10/01/2016	08/28/2018
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	10/01/2016	08/28/2018

Labeler - Starkey Hearing Technologies (055461479)

Revised: 12/2017

Document Id: 1e49e005-be90-4bb0-a5f3-ea131dd0d581

Set id: 98be1de1-1454-4408-9b82-7a10b940950e

Version: 3

Effective Time: 20171211

Starkey Hearing Technologies