Label at a glance#

ProductHealthy Ears

Active ingredientCARBAMIDE PEROXIDE

Label structure11 sections

Indications and uses

Uses: Ear wax removal aid and dries water in ears and relives water clogged ears.

Dosage and administration

Directions Apply 5-10 drops in each affected ear. Supervise children in the use of this product. Do not use for more than 4 days. Adults and children over 12 years of age: the tip of the applicator should not enter the ear canal. Keep the drops in the ear for several minutes by keeping the head tilted or placing cotton in the ear. Any wax remaining after treatment may be removed gently flushing the ear with the wa...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Purpose

Carbamide Peroxide 6.5% Ear wax removal aid

Uses

OTC - PURPOSE SECTION

Uses: Ear wax removal aid and dries water in ears and relives water clogged ears.

Warnings

WARNINGS SECTION

Warnings:

Do not us in the eyes.

Ask a doctor before use if you have: ear drainage or discharge, pain, irritation, or rash in th ear, had ear surgery, dizziness.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop usa and ask a doctor if irritation (too much burning) or pain occurs.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If preganant of breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

INDICATIONS & USAGE SECTION

Directions

Apply 5-10 drops in each affected ear. Supervise children in the use of this product.

Do not use for more than 4 days.

Adults and children over 12 years of age: the tip of the applicator should not enter the ear canal. Keep the drops in the ear for several minutes by keeping the head tilted or placing cotton in the ear. Any wax remaining after treatment may be removed gently flushing the ear with the warm water, using soft rubber bulb ear syringe.

Children 12 years or younger, only use directed by a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Apply 5-10 drops in each affected ear. Supervise children in the use of this product.

Do not use for more than 4 days.

Adults and children over 12 years of age: the tip of the applicator should not enter the ear canal. Keep the drops in the ear for several minutes by keeping the head tilted or placing cotton in the ear. Any wax remaining after treatment may be removed gently flushing the ear with the warm water, using soft rubber bulb ear syringe.

Children 12 years or younger, only use directed by a doctor.

Other Information

OTHER SAFETY INFORMATION

Store at controlled room temperature 15-30°C (59-86°F).

Tamper Evident Feature: Do not use if cello-band over cap is torn, broken or missing. Close tightly after use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Glycerin.

Keep out of reach children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Healthy Ears 0.5oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthy Ears

Ear wax removal aid and dries water in ears

Carbamide Peroxide 6.5%

Net Cont: 0.5 fl oz (15mL)

Healthy Ears

DailyMed RxNorm Mappings#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69469-650-05	Healthy Ears	14.7 mL in 1 BOTTLE, DROPPER	SOLUTION	14.7		2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Healthy Ears
Carbide Peroxide
GLYCERIN
WATER
CARBAMIDE PEROXIDE
HYDROGEN PEROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69469-650	69469-650-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Healthy Ears	CARBIDE PEROXIDE	Vitamex USA, Corp	25953441-cd8e-5038-e063-6294a90ae401	2025-06-23	Warnings	Exact identifier ndc (package): 69469-650-05 ndc (product): 69469-650 ndc11 (package): 69469065005 spl id: 38429bd1-d2d5-0b3c-e063-6394a90adc71 spl set id: 25953441-cd8e-5038-e063-6294a90ae401

Reported adverse events (FAERS/openFDA)#

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