HEALTHY EARS- carbide peroxide solution

Healthy Ears by

Drug Labeling and Warnings

Healthy Ears by is a Otc medication manufactured, distributed, or labeled by Vitamex USA, Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients: Purpose

Carbamide Peroxide 6.5% Ear wax removal aid

Uses

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

Warnings

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

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

If pregnant or breastfeeding

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

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

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

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 ingredients: Water, Glycerin.

Keep out of reach children

Keep out of reach of children

Healthy Ears 0.5oz

Healthy Ears

Ear wax removal aid and dries water in ears

Carbamide Peroxide 6.5%

Net Cont: 0.5 fl oz (15mL)

INGREDIENTS AND APPEARANCE

HEALTHY EARS 
carbide peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69469-650
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	6.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69469-650-05	14.7 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	10/28/2024

Labeler - Vitamex USA, Corp (054256676)