Carbamide

Carbamide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

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

This image is provided by the Wikipedia.

Mechanism of Action

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

Storage

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

Images

Drug Images

{{#ask: Page Name::Carbamide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL Ear Wax Cleansing Kit

Step 1 Ear Wax Removing Drops

Step 2 Ear Cleansing Spray

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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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

References

The contents of this FDA label are provided by the National Library of Medicine.

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