MedPath

Hydrogen peroxide

Generic Name
Hydrogen peroxide
Brand Names
Eskata, Orajel Mouth Sore Rinse
Drug Type
Small Molecule
Chemical Formula
H2O2
CAS Number
7722-84-1
Unique Ingredient Identifier
BBX060AN9V

Overview

Hydrogen peroxide is the simplest peroxide with a chemical formula H2O2. Hydrogen peroxide is an unstable compound in the presence of a base or catalyst, and is typically stored with a stabilizer in a weakly acidic solution. If heated to its boiling point, it may undergo potentially explosive thermal decomposition. Hydrogen peroxide is formed in the body of mammals during reduction of oxygen either directly in a two-electron transfer reaction . As a natural product of metabolism, it readily undergoes decomposition by catalase in normal cells . Due to its potent and broad-spectrum antimicrobial actions, hydrogen peroxide is used in both liquid and gas form for preservative, disinfection and sterilization applications as an oxidative biocide . It is used in industrial and cosmetic applications as a bleaching agent. Hydrogen peroxide is also considered as a generally recognized as safe compound by the FDA ; it is used as an antimicrobial agent in starch and cheese products, and as an oxidizing and reducing agent in products containing dried eggs, dried egg whites, and dried egg yolks.

Indication

Indicated to be used as a disinfectant and sterilizer.

Associated Conditions

  • Ear infection bacterial
  • Seborrheic Keratosis (SK)
  • Impacted ear wax
  • Superficial skin infections

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2022/10/06
Phase 1
Not yet recruiting
2021/08/27
Early Phase 1
Recruiting
2020/12/09
Phase 4
Completed
2019/05/10
Phase 2
Recruiting
Institute of Cancer Research, United Kingdom
2019/01/23
Phase 3
Completed
2018/09/27
Phase 3
Completed
2018/09/19
Early Phase 1
Completed
2018/05/25
Phase 2
Completed
2017/05/11
Phase 2
Completed
2017/01/12
Phase 4
Completed
University of Campinas, Brazil

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Aclaris Therapeutics, Inc.
71180-001
TOPICAL
40 mg in 100 mg
3/27/2019
Chain Drug Marketing Association, Inc
83324-290
TOPICAL
30 mg in 1 g
5/26/2025
Cardinal Health, 110 dba Leader
70000-0022
TOPICAL
3 mL in 100 mL
3/31/2025
Amerifoods Trading Co
61504-871
TOPICAL
30 mg in 1 mL
4/9/2025
Aclaris Therapeutics, Inc.
71180-002
TOPICAL
40 mg in 100 mg
3/27/2019
Amazon.Com Services LLC
72288-871
TOPICAL
30 mg in 1 mL
5/20/2025
Aplicare Products LLC
52380-1013
TOPICAL
3 mL in 100 mL
4/18/2025
GoBrands, Inc.
82501-0871
TOPICAL
30 mg in 1 mL
3/3/2025
TOP CARE (Topco Associates LLC)
36800-214
TOPICAL
2.65 mL in 100 mL
4/9/2025
Good Sense (Geiss, Destin & Dunn, Inc.)
50804-156
TOPICAL
2.65 mL in 100 mL
3/3/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
HYDROGEN PEROXIDE SOLN 6% STABILIZED
N/A
N/A
N/A
5/5/1982
VALIANT SOLUTION 6% (20 VOLUME)
N/A
N/A
N/A
4/29/1986
HYDROGEN PEROXIDE SOLUTION 3% 'JEN SHENG'
N/A
N/A
N/A
6/8/1999

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ORAJEL PERIOSEPTIC RINSE - 1.5%
del pharmaceutics (canada) inc.
02229965
Mouthwash/Gargle - Oral
1.5 %
10/21/1997
HIOXYL CREAM
seaford pharmaceuticals inc
02239473
Cream - Topical
1.5 %
5/31/1999
HYDROGEN PEROXIDE SOLUTION 3%
h.j. sutton industries ltd.
01995189
Solution - Topical
3 %
12/31/1993
HYDROGEN PEROXIDE LIQ 10VOL
stanley pharmaceuticals, a division of vita health products inc.
00179086
Liquid - Topical
3 %
12/31/1965
HYDROGEN PEROXIDE LIQ 6%
d.c. labs limited
00094005
Liquid - Topical
6 %
12/31/1951
HYDROGEN PEROXIDE TOPICAL SOL USP 3%
lawton's drug stores ltd.
00728764
Liquid - Topical
3 %
12/31/1987
HYDROGEN PEROXIDE TOPICAL SOLUTION USP
kolmar canada inc.
00723835
Solution - Topical
3 %
12/31/1986
HYDROGEN PEROXIDE SOLUTION 3%
ingram and bell inc.
00120510
Liquid - Topical
3 %
12/31/1951
PERIOSELECT HYDROGEN PEROXIDE SOLUTION 1.7%
sultan healthcare
00897604
Liquid - Dental
1.7 %
12/31/1992
HYDROGEN PEROXIDE TOP SOL 3% 10VOL ANTI
scott chemical canada
01948695
Liquid - Topical
3 %
12/31/1992

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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