Description
This guidance is intended to assist manufacturers, packers, and distributors who wish to present labeling information for their over-the-counter (OTC) human drug products using a column format.
Scope & Applicability
Product Classes
1Over-the-counter drug products for human use; The primary scope of the labeling guidance.
Stakeholders
4Entity to contact in case of overdose
Entity involved in investigational drug supply chain
Entity required to maintain records of lot numbers for food released; Entity required to establish and maintain records under subpart J.
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Regulatory Context
Attributes
5Requirement for readability of print
The unit of measure for oral dosage forms (e.g., tablet, teaspoonful).
Information required to be right justified on the label
Information required to be left justified on the label
Alternative labeling presentation style
Related CFR Sections (1)
- 21CFR201.66§ 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
(a) Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products. Where an OTC drug product is the subject of an applicable monograph or regulation that contains content and format requirements that conflict with this section, the content and format reRead full regulation →
Related Warning Letters (4)
- 2022-04-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangzhou Zhongkebaishi Health Industry Co., Ltd.
- 2021-10-12
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Notarika, S.A. de C.V.
- 2021-07-13
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangzhou Minghui Cosmetics Co., Ltd.
- 2021-03-30
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Distribuidora Lagunera del Norte S.A. de C.V.
See Also (8)
- Labeling OTC Human Drug Products -- Questions and Answers (Status: Final)
- 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 (Status: Final)
- Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide): Guidance for Industry (Status: Final)
- Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (Status: Final)
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (Status: Final)
- Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (Status: Draft)
- Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry (Status: Final)