Three key sources provide the labelling information needed for an Over-the-Counter (OTC) product. The first are general drug labelling requirements that apply to all drug products in the United States (21 CFR 201). The second source of labelling requirements come from regulations specific to all OTC products (21 CFR 201). Finally, each Over-the-Counter monograph may have specific labelling requirements relevant to OTC products in its category (21 CFR 330).
General Drug Labelling Requirements
As drug products, OTCs fall under the general drug labelling requirements in 21 CFR 201. These requirements include:
- The proprietary name of the drug
- The established name of the drug, if one exists
- An identifying lot or control number
- The name of the manufacturer, packer, or distributor of the drug
- The National Drug Code (NDC) number
- Adequate Directions for Use
- Statement of Ingredients
- An expiration date determined by appropriate stability testing
Over-the-Counter Labelling Requirements
Over-the-Counter products also have specific labelling requirements. Some of these requirements overlap with the general drug product labelling requirements. These requirements are outlined as follows:
- The statement of identity, including the established name of the drug and its pharmacological category.
- The declaration of net quantity, expressed in terms of weight, measure, or numerical count.
- A Drug Facts Table that outlines the key information about the OTC product.
- A pregnancy/breast-feeding warning for all OTC drug products that are intended for systemic absorption.
- A sodium/calcium/magnesium/potassium content declaration for any oral drug product containing more than a specified amount of the substance in question. This declaration must also include a warning to ask a doctor if the consumer has a diet with a restriction to one of these substances.
OTC Monograph Labelling Requirements
Finally, most Over-the-Counter product categories have their set of labelling requirements that can be found in their individual monographs. For example, the OTC Monograph for Sunscreen (21 CFR 352) products provides specific statements relevant only to Sunscreens. These describe the Uses and Directions for a sunscreen product, based on its SPF and Water Resistance claims, as well as additional Warnings required specifically for sunscreens.
The Drug Facts Table
The secondary packaging, or the immediate container if there is no outside container, of every OTC drug product must include a Drug Facts table. In addition to strict content requirements, there are also very specific requirements around the appearance of the Drug Facts Table. Failure to comply with the drug labelling requirements could lead to regulatory action by the FDA.
The Drug Facts Table includes information on the following sections.
Drug Facts Title
Each Drug Facts Table should be headed with a “Drug Facts” title.
Active Ingredients
The Active Ingredients heading should be followed by the dosage unit. This section should then list the active ingredient and the quantity of each active ingredient per dosage unit.
Purpose
The Purpose section lists the general pharmacological category or the principal intended actions of the drug. If the drug consists of more than one active ingredient, then the purpose of each active ingredient should be listed. There may also be specific statements for this section outlined within an OTC drug monograph.
Uses
The Uses section lists the indications of the specific drug product.
Warnings
The Warnings section must include several warning statements specifically outlined for OTC products and specific to a product’s OTC monograph. It also includes warnings regarding the situations in which it would be appropriate to ask a doctor before use, as well as warnings about side effects, and a contact number for reporting them.
Directions
The Directions section should include all conditions, purposes, or uses for which the drug is intended, as described in the product’s OTC monograph. In addition, this section should include:
- The quantity of dose for each intended use
- The frequency of application or administration
- The duration of application or administration
- The time of administration or application in relation to other time factors
- The route or method of application or administration
- Any relevant preparation for use
Other Information
The Other Information section is used for required information that does not fit in one of the other categories. The key use for this section is the listing of ingredients that require a specific declaration, such as phenylalanine/aspartame, sodium, calcium, magnesium, potassium, and sulfites.
Inactive Ingredients
The Inactive Ingredient section should list the established name of each inactive ingredient.
Would you like to find out more about OTC product labeling in the United States?
To find out more, please contact Alexander Detre.
Three key sources provide the labelling information needed for an Over-the-Counter (OTC) product. The first are general drug labelling requirements that apply to all drug products in the United States (21 CFR 201). The second source of labelling requirements come from regulations specific to all OTC products (21 CFR 201). Finally, each Over-the-Counter monograph may have specific labelling requirements relevant to OTC products in its category (21 CFR 330).
General Drug Labelling Requirements
As drug products, OTCs fall under the general drug labelling requirements in 21 CFR 201. These requirements include:
- The proprietary name of the drug
- The established name of the drug, if one exists
- An identifying lot or control number
- The name of the manufacturer, packer, or distributor of the drug
- The National Drug Code (NDC) number
- Adequate Directions for Use
- Statement of Ingredients
- An expiration date determined by appropriate stability testing
Over-the-Counter Labelling Requirements
Over-the-Counter products also have specific labelling requirements. Some of these requirements overlap with the general drug product labelling requirements. These requirements are outlined as follows:
- The statement of identity, including the established name of the drug and its pharmacological category.
- The declaration of net quantity, expressed in terms of weight, measure, or numerical count.
- A Drug Facts Table that outlines the key information about the OTC product.
- A pregnancy/breast-feeding warning for all OTC drug products that are intended for systemic absorption.
- A sodium/calcium/magnesium/potassium content declaration for any oral drug product containing more than a specified amount of the substance in question. This declaration must also include a warning to ask a doctor if the consumer has a diet with a restriction to one of these substances.
OTC Monograph Labelling Requirements
Finally, most Over-the-Counter product categories have their set of labelling requirements that can be found in their individual monographs. For example, the OTC Monograph for Sunscreen (21 CFR 352) products provides specific statements relevant only to Sunscreens. These describe the Uses and Directions for a sunscreen product, based on its SPF and Water Resistance claims, as well as additional Warnings required specifically for sunscreens.
The Drug Facts Table
The secondary packaging, or the immediate container if there is no outside container, of every OTC drug product must include a Drug Facts table. In addition to strict content requirements, there are also very specific requirements around the appearance of the Drug Facts Table. Failure to comply with the drug labelling requirements could lead to regulatory action by the FDA.
The Drug Facts Table includes information on the following sections.
Drug Facts Title
Each Drug Facts Table should be headed with a “Drug Facts” title.
Active Ingredients
The Active Ingredients heading should be followed by the dosage unit. This section should then list the active ingredient and the quantity of each active ingredient per dosage unit.
Purpose
The Purpose section lists the general pharmacological category or the principal intended actions of the drug. If the drug consists of more than one active ingredient, then the purpose of each active ingredient should be listed. There may also be specific statements for this section outlined within an OTC drug monograph.
Uses
The Uses section lists the indications of the specific drug product.
Warnings
The Warnings section must include several warning statements specifically outlined for OTC products and specific to a product’s OTC monograph. It also includes warnings regarding the situations in which it would be appropriate to ask a doctor before use, as well as warnings about side effects, and a contact number for reporting them.
Directions
The Directions section should include all conditions, purposes, or uses for which the drug is intended, as described in the product’s OTC monograph. In addition, this section should include:
- The quantity of dose for each intended use
- The frequency of application or administration
- The duration of application or administration
- The time of administration or application in relation to other time factors
- The route or method of application or administration
- Any relevant preparation for use
Other Information
The Other Information section is used for required information that does not fit in one of the other categories. The key use for this section is the listing of ingredients that require a specific declaration, such as phenylalanine/aspartame, sodium, calcium, magnesium, potassium, and sulfites.
Inactive Ingredients
The Inactive Ingredient section should list the established name of each inactive ingredient.
Would you like to find out more about OTC product labeling in the United States?
To find out more, please contact Alexander Detre.
