(a) General. Except as otherwise provided in paragraph (b) or (c) of this section, the immediate container of each article shall, before removal from the manufacturer's premises, bear the following information either directly on the container or on a label securely attached to it:

(1) The name, trade name or brand name of the article; and

(2) The name and address (city and State) of the manufacturer or distributor of the article.

(b) Articles for external human use. Except as provided in paragraph (c) of this section, an article intended for external human use shall, before removal from the manufacturer's premises, have a label affixed to its immediate container identifying the name, trade name or brand name of the article. If the volume of the article in the container exceeds 8-fluid ounces, the label shall also show the information required by paragraph (b) (1) or (2) of this section.

(1) If the article was packaged or bottled by the person who manufactured it, the label shall identify—

(i) The manufacturer's name and the address (city and State) of the actual place or places where article was manufactured, or

(ii) 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 shall send a notice explaining the coding system to the appropriate TTB officer, or

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

(2) If the article was packaged or bottled by a person other than the manufacturer of the article, the label shall identify—

(i) The name and address (city and State) of the person by whom or for whom the article was packaged or bottled, and

(ii) The permit number of the manufacturer or distributor.

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

(c) Shipment of unlabeled articles. A manufacturer may, subject to the approval of the appropriate TTB officer and compliance with §20.133, remove an unlabeled article from the manufacturer's premises, if the outer containers of the article are labeled with the name, trade name or brand name of the article and the names and addresses (city and State) of the manufacturer and the consignee.

(d) Use of the words “denatured alcohol.” If the words “denatured alcohol” appear on the label of an article, the label shall also have a name, trade name or brand name which appears as conspicuously as the words “denatured alcohol.”

(e) Use of the words “rubbing alcohol.” If the words “rubbing alcohol” appear on the label of an article, (1) the article shall be made in accordance with §20.118 of this part, and (2) the label (i) shall have the words “rubbing alcohol” in letters of the same color and size, (ii) shall identify the name and address (city and State) of the manufacturer or bottler, (iii) shall state the alcohol content as 70% by volume with no reference to the proof strength, and (iv) shall have 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, shall not be labeled “Rubbing Alcohol” unless the label informs the consumer that the preparation was not made with specially denatured alcohol.

(f) Distributor labeling. Distributors of an article may place minimal identifying information (name, address and a phrase such as “distributed by”) on the label of that article (or on an additional label) without qualifying in any manner under this part; provided:

(1) The article is produced, packaged and labeled as provided in this part; and

(2) The distributor does not produce, repackage or reprocess the article.

(Approved by the Office of Management and Budget under control number 1513-0061)

[T..D ATF-199, 50 FR 9162, Mar. 6, 1985, as amended by ATF-332, 57 FR 40849, Sept. 8, 1992; T.D. TTB-140, 81 FR 59459, Aug. 30, 2016]