SDS/CDA TUTORIAL

Labeling Requirements

The following information is provided to assist with labeling articles. For complete TTB labeling regulations please see 27 CFR §§ 20.13420.137. Industry members are required to comply with TTB labeling regulations.  Additionally, other Federal agencies have regulations which may also affect the labeling of article.

General

Except in the case of articles for external human use and certain unlabeled articles (see specific rules below), before removal from the manufacturer's premises the label on the article's immediate container, or a label securely attached to the container, must contain:

  • Name, trade name or brand name of the article; and

  • Name and address (city and state) of the manufacturer or distributor of the article.

Articles Intended for External Human Use

Before removal from the manufacturer's premises the label on the article's immediate container must contain:

  • Name, trade name, or brand name of the article.

If the volume of the article in the container exceeds 8-fluid ounces, the label must also contain the following:

  • For an article that was packaged or bottled by the person who manufactured it:

    • The manufacturer's name and the address (city and state) of the actual place or places where the article was manufactured;

or

    • The name and principal office address (city and state) of the manufacturer, and the permit number or numbers of the place or places of manufacture. However, in lieu of such permit number or numbers, the place or places where the manufacturing operation occurred may be indicated by a coding system. Prior to using a coding system, the manufacturer must send a notice explaining the coding system to the appropriate TTB officer;

or

    • The manufacturer's permit number and the name and address (city and state) of the person for whom the article was packaged and bottled.

  • For an article that was packaged or bottled by a person other than the manufacturer of the article:

    • The name and address (city and state) of the person by whom or for whom the article was packaged or bottled; and

    • The permit number of the manufacturer or distributor.

If a permit number is required to be shown on the label, it may be shown utilizing a State code number, in accordance with 27 CFR § 20.135.

Shipment of Unlabeled Articles

An unlabeled article may be removed from a manufacture's premises (subject to the approval of the appropriate TTB officer and compliance with 27 CFR § 20.133) if the outer container of the article is labeled with:

  • Name, trade name or brand name of the article; and

  • Name and address (city and state) of the manufacturer and the consignee.

Use of Denatured Alcohol on a Label

If the words "denatured alcohol" appear on the label of an article, the label must also contain:

  • Name, trade name or brand name which appears as noticeably as the words "denatured alcohol."

Use of Rubbing Alcohol on a Label

If the words "rubbing alcohol" appear on the label of an article:

  • The article must be made in accordance with 27 CFR § 20.118; and

  • The label must also include:

    • The words "rubbing alcohol" in letters of the same color and size;

    • The name and address (city and state) of the manufacturer or bottler;

    • The alcohol content as 70% by volume with no reference to the proof strength; and

    • The warning "For external use only. If taken internally, will cause serious gastric disturbances."

An alcohol rub made from any other material, such as isopropyl alcohol, must not be labeled "Rubbing Alcohol" unless the label informs the consumer that the preparation was not made with specially denatured alcohol.

Labeling Information for Distributors:

Distributors of an article may place minimal identifying information on the label (or on an additional label) such as:

  • Name;

  • Address; and

  • A phrase such as "distributed by"

provided that:

  • The article is produced, packaged and labeled as provided in 27 CFR part 20; and

  • The distributor does not produce, repackage or reprocess the article.

 

Page last reviewed/updated: 12/07/2018