Carbamide

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

# Overview
Carbamide is a OTC emollient that is FDA approved for the treatment of excessive ear wax.   Common adverse reactions include allergic reactions.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- For occasional use as an aid to soften, loosen, and remove excessive ear wax.

### Dosage
- FOR USE IN THE EAR ONLY.  Adults and children over 12 years of age:  tilt head sideways and place 5 to 10 drops into ear.  Tip of applicator should not enter ear canal.  Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear.  Use twice daily for up to four days if needed, or as directed by a doctor.  Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age:  consult a doctor.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Carbamide in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Carbamide in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### Indications
- For occasional use as an aid to soften, loosen, and remove excessive ear wax.

### Dosage
- FOR USE IN THE EAR ONLY.  Adults and children over 12 years of age:  tilt head sideways and place 5 to 10 drops into ear.  Tip of applicator should not enter ear canal.  Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear.  Use twice daily for up to four days if needed, or as directed by a doctor.  Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age:  consult a doctor.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Carbamide in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Carbamide in pediatric patients.

# Contraindications
There is limited information regarding Carbamide Contraindications in the drug label.

# Warnings
- Do not use: if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor.  If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor.  For more than four consecutive days.
- When using this product: avoid contact with the eyes.
- Stop use and ask a doctor if: excessive ear wax remains after use of this product for four consecutive days.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

# Adverse Reactions

## Clinical Trials Experience
- allergic reactions

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Carbamide in the drug label.

# Drug Interactions
There is limited information regarding Carbamide Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Pregnancy Category
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Carbamide in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Carbamide during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Carbamide with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Carbamide with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Carbamide with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Carbamide with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Carbamide with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Carbamide in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Carbamide in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Carbamide in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Carbamide in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- topical ear drops

### Monitoring
There is limited information regarding Monitoring of Carbamide in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Carbamide in the drug label.

# Overdosage
There is limited information regarding Overdose of Carbamide in the drug label.

# Pharmacology

## Mechanism of Action
There is limited information regarding Carbamide Mechanism of Action in the drug label.

## Structure
- Active Ingredient
- Carbamide Peroxide 6.5%
- Inactive ingredients
- Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Oil

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Carbamide in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Carbamide in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Carbamide in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Carbamide in the drug label.

# How Supplied
There is limited information regarding Carbamide How Supplied in the drug label.

## Storage
There is limited information regarding Carbamide Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL
Ear Wax Cleansing Kit
Step 1 Ear Wax Removing Drops
Step 2 Ear Cleansing Spray

### Ingredients and Appearance

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Carbamide in the drug label.

# Precautions with Alcohol
- Alcohol-Carbamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- EAR WAX REMOVING DROPS  CARBAMIDE PEROXIDE

# Look-Alike Drug Names
There is limited information regarding Carbamide Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price