Registration Dossier
Registration Dossier
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EC number: 202-327-6 | CAS number: 94-36-0
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Adequacy of study:
- weight of evidence
Data source
Reference
- Reference Type:
- other: Official journal
- Title:
- Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-The- Counter Human Use; Final Rule
- Author:
- US Food and Drug Administration
- Year:
- 2 010
- Bibliographic source:
- Federal Register, 75(42):9767-9777
Materials and methods
- Endpoint addressed:
- other: Acne vulgaris treatment
Test material
- Reference substance name:
- Dibenzoyl peroxide
- EC Number:
- 202-327-6
- EC Name:
- Dibenzoyl peroxide
- Cas Number:
- 94-36-0
- Molecular formula:
- C14H10O4
- IUPAC Name:
- diphenylperoxyanhydride
Constituent 1
Method
- Type of population:
- general
- Route of exposure:
- dermal
- Reason of exposure:
- other: Therapeutical
Results and discussion
- Results of examinations:
- Benzoyl peroxide is recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products.
Applicant's summary and conclusion
- Executive summary:
We, The US Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this final rule includes new warnings and directions required for OTC acne drug products containing benzoyl peroxide. We are also revising labeling for OTC topical acne drug products containing resorcinol, resorcinol monoacetate, salicylic acid and/or sulfur to meet OTC drug labeling content and format requirements in a certain FDA regulation. This final rule is part of our ongoing review of OTC drug products and represents our conclusions on benzoyl p roxide in OTC acne drug products.
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