Carbamide peroxide

Identification

Logo pink
Are you a
new drug developer?
Contact us to learn more about our customized products and solutions.
Logo pink
Stay in the know!
As part of our commitment to providing the most up-to-date drug information, we will be releasing #DrugBankUpdates with our newly added curated drug pages.
#DrugBankUpdates
Name
Carbamide peroxide
Accession Number
DB11129
Type
Small Molecule
Groups
Approved
Description

Carbamide peroxide, also known as urea-hydrogen peroxide, is a water-soluble, white crystalline solid compound consisting of hydrogen peroxide and urea. As it is a source of hydrogen peroxide, it can be found in disinfecting and dental bleaching products. Some adverse effects of carbamide peroxide as a dental bleaching agent include dentin sensitivity and/or gingival irritation led by unstable and reactive H+ free radicals and low pH from prolonged use. It may also alter enamel surface morphology via enamel mineral loss and surface roughening 1. The FDA considers carbamide peroxide to be safe in oral mucosal injury drug products as an oral wound healing agent, although there is insufficient data to establish general recognition of the effectiveness of this ingredient as an oral wound healing agent 6. It is available in OTC otic drugs as non-water, non-oil-based solutions used to soften, loosen and remove excessive ear wax, or cerumen.

Structure
Thumb
Synonyms
  • Carbamide peroxide
  • Hydrogen peroxide carbamide
  • Urea dioxide
  • Urea hydrogen peroxide
  • Urea peroxide
Active Moieties
NameKindUNIICASInChI Key
Hydrogen peroxideunknownBBX060AN9V7722-84-1MHAJPDPJQMAIIY-UHFFFAOYSA-N
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Endoperox 100%TabletDentalSeptodont1988-12-312000-08-03Canada
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

    Learn more
  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

    Learn more
Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Audiologists Choice EARWAX REMOVAL SYSTEM Earwax RemovalLiquid65 mg/1mLTopicalOaktree Products Inc.2014-11-28Not applicableUs
AuralytLiquid7.8 mg/12mLTopicalMenper Distributors, Inc2014-01-01Not applicableUs
Auro Ear Wax RemoverLiquid1.44 mL/22mLAuricular (otic)Insight Pharmaceuticals2010-07-01Not applicableUs
Best Choice Earwax Removal KitLiquid65 mg/1mLTopicalValu Merchandisers, Co.2014-11-27Not applicableUs
Clear canal Earwax softener dropsSolution / drops6.5 mg/1mLAuricular (otic)NeilMed Pharmaceuticals, Inc.2019-02-16Not applicableUs
ClearCanal Ear Wax Softerner DropsSolution / drops65 mg/1mLAuricular (otic)NeilMed Pharmaceuticals, Inc.2011-08-24Not applicableUs
Cvs Earwax Rem CvsKit6.5 g/100mLTopicalCVS Health2014-11-12Not applicableUs
CVS Earwax Removal AidLiquid65 mg/1mLTopicalCVS Health2011-04-25Not applicableUs
DebroxLiquid0.065 mg/1mLAuricular (otic)Remedy Repack2015-02-102016-02-10Us
DebroxLiquid0.065 mg/1mLAuricular (otic)A-S Medication Solutions2012-08-01Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

    Learn more
  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

    Learn more
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Dr.Whitiss 15%Carbamide peroxide (150 mg/1g) + Sodium fluoride (2.5 mg/1g)Gel, dentifriceDentalNIBEC Co., Ltd.2015-06-07Not applicableUs
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Lutooth Tooth WhiteningCarbamide peroxide (8.3 g/100mL)KitDentalDent-White Co LTD2016-05-052016-05-06Us
Thera-EarCarbamide peroxide (7.15 g/79.37mL)Solution / dropsTopicalHarmony Labs, Inc.2008-01-012011-04-06Us
International/Other Brands
Aquadrate / Balneum plus / Calmurid / Eucerin / Flexifoot / Flexitol / Hydromol intensive / Nutraplus / Sential E / St.James balm / Ureaphil
Categories
UNII
31PZ2VAU81
CAS number
124-43-6
Weight
Average: 94.07
Monoisotopic: 94.037842061
Chemical Formula
CH6N2O3
InChI Key
AQLJVWUFPCUVLO-UHFFFAOYSA-N
InChI
InChI=1S/CH4N2O.H2O2/c2-1(3)4;1-2/h(H4,2,3,4);1-2H
IUPAC Name
peroxol; urea
SMILES
OO.NC(N)=O

Pharmacology

Indication

Indicated as a dental bleaching agent.

Indicated as an oral wound healing agent in oral mucosal injuries.

Indicated as an aid in the removal of hardened ear wax.

Pharmacodynamics

Carbamide peroxide releases hydrogen peroxide and free radicals upon contact with water or outer surfaces of ear and tooth. Hydrogen peroxide exerts cerumenolytic, enamel-bleaching and antiseptic actions. In vitro, the chemical stability of ceramics against bleaching agents was observed after treatment with 15% carbamide peroxide for 56 h, 16% carbamide peroxide for 126 h, 10% or 15% carbamide peroxide and 38% hydrogen peroxide for 30 minutes or 45 minutes, respectively 1. According to in vitro studies, high (37%) or low (10 or 16%) concentrated carbamide peroxide agents were similarly effective as oral bleaching agents 2. Treatment with carbamide peroxide may lead to demineralization which involves decreased mineral content of enamel calcium, phosphate, and fluoride, and alteration of the chemical, structural, and mechanical properties 3. Carbamide peroxide may affect the organic components of the enamel and lead to increased susceptibility to erosion, fracture stability or decreased abrasion resistance of the treated area 3.

Mechanism of action

Carbamide peroxide release hydrogen peroxide upon contact with teeth, which is a strong oxidizing and bleaching agent. It also release free radicals such as H+ or H3O+ 1. Hydrogen peroxide also acts as an antiseptic, especially in sites with relative anaerobiosis. Following otic administration, carbamide peroxide complex releases hydrogen peroxide that breaks up the hardened wax. The hydrogen peroxide component, which further breaks down into water, is also a cerumenolytic that hydrates the desquamated sheets of corneocytes, which are the major constituent of cerumen plugs 4. The glycerol and urea facilitates softening of the cerumen, either with or without syringing 5. Both hydrogen peroxide and urea mildly induce keratolysis with disintegration of the ear wax to help reduce the keratin-load in the ear debris and allow other active components to reach the skin under the debris 4,5.

Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

Learn more
Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

Learn more
Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

Learn more
Absorption

Upon treatment into the external auditory canal or the dental cavity, exposure to carbamide peroxide is limited to the intimate contact with the treated area without any systemic absorption.

Volume of distribution

No established pharmacokinetic data.

Protein binding

No established pharmacokinetic data.

Metabolism

No established pharmacokinetic data.

Route of elimination

No established pharmacokinetic data.

Half life

No established pharmacokinetic data.

Clearance

No established pharmacokinetic data.

Toxicity

Oral LD50 in rat is >2000 mg/kg MSDS.

Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

References

General References
  1. Ourique SA, Arrais CA, Cassoni A, Ota-Tsuzuki C, Rodrigues JA: Effects of different concentrations of carbamide peroxide and bleaching periods on the roughness of dental ceramics. Braz Oral Res. 2011 Sep-Oct;25(5):453-8. [PubMed:22031060]
  2. Meireles SS, Fontes ST, Coimbra LA, Della Bona A, Demarco FF: Effectiveness of different carbamide peroxide concentrations used for tooth bleaching: an in vitro study. J Appl Oral Sci. 2012 Mar-Apr;20(2):186-91. [PubMed:22666835]
  3. Bollineni S, Janga RK, Venugopal L, Reddy IR, Babu PR, Kumar SS: Role of fluoridated carbamide peroxide whitening gel in the remineralization of demineralized enamel: An in vitro study. J Int Soc Prev Community Dent. 2014 May;4(2):117-21. doi: 10.4103/2231-0762.137638. [PubMed:25254197]
  4. Hand C, Harvey I: The effectiveness of topical preparations for the treatment of earwax: a systematic review. Br J Gen Pract. 2004 Nov;54(508):862-7. [PubMed:15527615]
  5. electronic Medicines Compendium (eMC): Otex Ear Drops [Link]
  6. CFR - Code of Federal Regulations Title 21: Sec. 310.534 Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. [Link]
External Links
PubChem Compound
31294
PubChem Substance
347827910
ChemSpider
29034
RxNav
47686
ChEBI
75178
ChEMBL
CHEMBL3184026
Wikipedia
Hydrogen_peroxide_-_urea
MSDS
Download (62.2 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1RecruitingTreatmentOtitis Media (OM)1
1RecruitingTreatmentChronic suppurative Otitis media1
1, 2CompletedTreatmentEar Diseases / Otitis / Otitis Externa / Otorhinolaryngologic Diseases1
2CompletedTreatmentAcute Otitis Externa1
2CompletedTreatmentEar Diseases / Otitis / Otitis Externa / Otorhinolaryngologic Diseases1
2CompletedTreatmentPain1
3CompletedTreatmentAcute Otitis Media1
3CompletedTreatmentTooth Sensitivity1
3TerminatedTreatmentAcute Otitis Media1
4CompletedTreatmentAtopic Dermatitis (AD)1
Not AvailableCompletedPreventionPigmentation From Visible Light1
Not AvailableCompletedSupportive CareOtitis Media (OM)1
Not AvailableCompletedTreatmentAllergy Pollen / Atopic Dermatitis (AD)1
Not AvailableCompletedTreatmentTooth Discoloration1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
LiquidTopical7.8 mg/12mL
LiquidAuricular (otic)1.44 mL/22mL
Solution / dropsAuricular (otic)6.5 mg/1mL
LiquidTopical65 mg/1mL
LiquidAuricular (otic)0.065 mg/1mL
SolutionTopical65 mg/1mL
Gel, dentifriceDental0.083 g/1g
Gel, dentifriceDental10 g/100g
Gel, dentifriceDental
Gel, dentifriceDental15 g/100g
Gel, dentifriceDental20 g/100g
Gel, dentifriceDental35 g/100g
KitTopical6.5 g/100mL
LiquidAuricular (otic)6.5 mg/100mL
LiquidTopical6.5 g/100mL
Solution / dropsTopical65 mg/1mL
LiquidAuricular (otic)65 mg/1mL
LiquidAuricular (otic)6.5 g/100mL
Solution / dropsAuricular (otic)81.86 mg/1mL
KitAuricular (otic)6.5 g/100mL
SolutionAuricular (otic)81.86 mg/1mL
TabletDental
LiquidAuricular (otic)0.065 g/1g
LiquidOral100 mg/1mL
Solution / dropsTopical6.5 g/100mL
KitTopical65 mg/1mL
KitDental8.3 g/100mL
Gel, dentifriceDental15 g/100mL
Gel, dentifriceDental8.3 g/100mL
LiquidAuricular (otic)
LiquidOral0.1 mg/1mL
Solution / dropsAuricular (otic)65 mg/1mL
Solution / dropsTopical7.15 g/79.37mL
Solution / dropsAuricular (otic)6.5 g/100mL
CrystalNot applicable1 g/1g
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
PropertyValueSource
melting point (°C)75-85MSDS
water solubility500 g/L at °CMSDS
Predicted Properties
PropertyValueSource
Water Solubility412.0 mg/mLALOGPS
logP-1.8ALOGPS
logP-1.4ChemAxon
logS0.84ALOGPS
pKa (Strongest Acidic)15.73ChemAxon
pKa (Strongest Basic)-2.4ChemAxon
Physiological Charge0ChemAxon
Hydrogen Acceptor Count1ChemAxon
Hydrogen Donor Count2ChemAxon
Polar Surface Area69.11 Å2ChemAxon
Rotatable Bond Count0ChemAxon
Refractivity13.14 m3·mol-1ChemAxon
Polarizability5.1 Å3ChemAxon
Number of Rings0ChemAxon
Bioavailability1ChemAxon
Rule of FiveYesChemAxon
Ghose FilterNoChemAxon
Veber's RuleNoChemAxon
MDDR-like RuleNoChemAxon
Predicted ADMET features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
SpectrumSpectrum TypeSplash Key
Predicted MS/MS Spectrum - 10V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 20V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 40V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 10V, Negative (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 20V, Negative (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 40V, Negative (Annotated)Predicted LC-MS/MSNot Available

Taxonomy

Description
This compound belongs to the class of organic compounds known as ureas. These are compounds containing two amine groups joined by a carbonyl (C=O) functional group.
Kingdom
Organic compounds
Super Class
Organic acids and derivatives
Class
Organic carbonic acids and derivatives
Sub Class
Ureas
Direct Parent
Ureas
Alternative Parents
Organopnictogen compounds / Organonitrogen compounds / Organic oxides / Hydrocarbon derivatives / Carbonyl compounds
Substituents
Urea / Organic nitrogen compound / Organic oxygen compound / Organopnictogen compound / Organic oxide / Hydrocarbon derivative / Organooxygen compound / Organonitrogen compound / Carbonyl group / Aliphatic acyclic compound
Molecular Framework
Aliphatic acyclic compounds
External Descriptors
mixture (CHEBI:75178)

Drug created on December 03, 2015 09:51 / Updated on February 06, 2020 13:04