Active Ingredients
Active Ingredients: Purpose
Carbamide Peroxide 6.5% Ear wax removal aid
Healthy Ears Solution
FDA Label NDC 69469-650
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vitamex Usa, Corp for the product Healthy Ears (NDC 69469-650). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, warnings, stop use and ask a doctor, if pregnant or breastfeeding, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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)
* Please review the disclaimer below.
