Healthy Ears 0.5oz

Healthy Ears 0.5oz
SPL v2
SPL
SPL Set ID 25953441-cd8e-5038-e063-6294a90ae401
Route
AURICULAR (OTIC)
Published
Effective Date 2024-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (6.5 mg)
Inactive Ingredients
Glycerin Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-28

Description

Active Ingredients: Purpose Carbamide Peroxide 6.5% Ear wax removal aid


Medication Information

Description

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.

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.

Active Ingredients

Active Ingredients: Purpose

Carbamide Peroxide 6.5% Ear wax removal aid

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)

Inactive Ingredients

Inactive ingredients: Water, Glycerin.

Stop Use and Ask A Doctor

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

Keep Out of Reach Children

Keep out of reach of children

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.


Structured Label Content

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.

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.

Active Ingredients

Active Ingredients: Purpose

Carbamide Peroxide 6.5% Ear wax removal aid

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)

Inactive Ingredients

Inactive ingredients: Water, Glycerin.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

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

Keep Out of Reach Children (Keep out of reach children)

Keep out of reach of children

If Pregnant Or Breastfeeding (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.


Advanced Ingredient Data


Raw Label Data

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