Otix Ear wax Removal System Ear wax and Bulb

Manufacturer: Bell Pharmaceuticals, Inc.
Effective date: 2023-12-14
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:04:47

Label at a glance#

ProductOtix Ear wax Removal System Ear wax and Bulb

Active ingredientCARBAMIDE PEROXIDE

Label structure8 sections

Indications and uses

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

Dosage and administration

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...

Contacts and useful links#

PhoneLabel contact1-800-328-5890

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For use in the ear only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

ear drainage or discharge
ear pain
irritation, or rash in the ear
dizziness
an injury or perforation (hole) of the ear drum
recently had ear surgery

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

you need to use for more than 4 days
excessive earwax remains after use of this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 ear syringe Children Under 12 years: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

Avoid exposing bottle to excessive heat and direct sunlight
Store bottle in the outer carton
Keep cap in bottle when not in use
Product foams on contact with earwax due to release of oxygen. There may be an assoiciated crackling sound.
Do not use if tamper-evident safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

OTC - QUESTIONS SECTION

1-800-328-5890

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kit

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
702050	carbamide peroxide 6.5 % Otic Solution	PSN	2
2588948	Otix 6.5 % Otic Solution	PSN	2
2588948	carbamide peroxide 65 MG/ML Otic Solution [Otix]	SBD	2
702050	carbamide peroxide 65 MG/ML Otic Solution	SCD	2
702050	carbamide peroxide 6.5 % Otic Solution	SY	2
2588948	Otix 65 MG/ML Otic Solution	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
15579-838-34	Otix Ear wax Removal System Ear wax and Bulb	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15 mL	65 mg in 1mL	2
15579-838-34	Otix Ear wax Removal System Ear wax and Bulb	1 in 1 BOX	SOLUTION/ DROPS		65 mg in 1mL	2
15579-839-33	Otix Ear wax Removal System Ear wax and Bulb	1 in 1 KIT	KIT	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15579-838	OTIX EAR WAX REMOVAL SYSTEM EAR WAX AND BULB (CARBAMIDE PEROXIDE) KIT [BELL PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC	20231219_15868798-28cd-4495-9baf-711e81ad8bdd.zip
15579-839	OTIX EAR WAX REMOVAL SYSTEM EAR WAX AND BULB (CARBAMIDE PEROXIDE) KIT [BELL PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 3 package rows	20231219_15868798-28cd-4495-9baf-711e81ad8bdd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Otix Ear wax Removal System Ear wax and Bulb
CARBAMIDE PEROXIDE
Otix Ear wax Removal Drops
ANHYDROUS CITRIC ACID
GLYCERIN
PROPYLENE GLYCOL
SODIUM CITRATE
SODIUM LAURYL SULFATE
WATER
HYDROGEN PEROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
15579-839	15579-839-33
15579-838	15579-838-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
WATER	059QF0KO0R	IACT
CARBAMIDE PEROXIDE	31PZ2VAU81	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Otix Ear wax Removal System Ear wax and Bulb	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	15868798-28cd-4495-9baf-711e81ad8bdd	2023-12-14	Warnings	Exact identifier ndc (package): 15579-838-34 ndc (package): 15579-839-33 ndc (product): 15579-839 ndc11 (package): 15579083834 ndc11 (package): 15579083933 spl id: 0c7fb23c-2434-ee25-e063-6394a90a9f53 spl set id: 15868798-28cd-4495-9baf-711e81ad8bdd
Otix Ear wax Removal Drops	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	0e70ab09-9360-4ab6-a1fe-6f82af392581	2023-12-14	Warnings	Exact identifier ndc (package): 15579-838-34 ndc (product): 15579-838 ndc11 (package): 15579083834

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.