Healthy Ears
Healthy Ears 0.5oz
25953441-cd8e-5038-e063-6294a90ae401
HUMAN OTC DRUG LABEL
Jun 23, 2025
Vitamex USA, Corp
DUNS: 054256676
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carbide Peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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)
INDICATIONS & USAGE SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Active Ingredients: Purpose
Carbamide Peroxide 6.5% Ear wax removal aid
OTC - PURPOSE SECTION
Uses
Uses: Ear wax removal aid and dries water in ears and relives water clogged ears.
WARNINGS SECTION
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.
OTC - STOP USE SECTION
Stop use and ask a doctor
Stop usa and ask a doctor if irritation (too much burning) or pain occurs.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
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 INGREDIENT SECTION
Inactive Ingredients
Inactive ingredients: Water, Glycerin.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach children
Keep out of reach of children