# Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/small-entity-compliance-guide/topical-acne-drug-products-for-over-the-counter-human-use-revision-of-labeling-and-classification-of-benzoyl-peroxide-as-safe-and-effective-guidance-for-industry/c1be2f8e-363e-4a2e-8fcb-ff9ccf72373a

> FDA guidance document: Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective:  Guidance for Industry. Issue date: June 21, 2011. Get complete insights and analysis.

---

## Details

- Title: Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective:  Guidance for Industry
- Communication Type: Small Entity Compliance Guide
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2011-06-21
- Last Changed: 2019-10-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0404">FDA-2011-D-0404</a>

## Related Documents

- ["Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications"](https://www.globalkeysolutions.net/guidances/guidance-document/toll-free-number-labeling-and-related-requirements-for-over-the-counter-and-prescription-drugs-marketed-with-approved-applications/3dd055ae-75ac-4cc5-9844-15edd771787b)
- [PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide](https://www.globalkeysolutions.net/guidances/small-entity-compliance-guide/pet-drugs-current-good-manufacturing-practice-cgmp-small-entity-compliance-guide/26400201-bc4d-4183-a80f-e3cd71291dfb)
- [Organ-Specific Warnings:  Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide](https://www.globalkeysolutions.net/guidances/small-entity-compliance-guide/organ-specific-warnings-internal-analgesic-antipyretic-and-antirheumatic-drug-products-for-over-the-counter-human-use-small-entity-compliance-guide/39718e83-6e62-481c-9f54-d26ba46bb38f)
