3015. Misbranding of Amberin.   U. S. v. 8 Cartons   *    *    *.    (F. D. C. No. 27447.
Sample No. 40866-K.)
LIBEL FILED :   July 6,1949, Western District of Washington.
886056-50?2
ALLEGED SHIPMENT : On or about April 20, 1949, by the Stanley Drug Products
Co., from Portland, Oreg.
PRODUCT: 18 cartons, each, containing 6 dozen 4-ounce bottles, of Amberin at
Seattle, Wash. Examination showed that the product consisted essentially of
acetone 84 percent, volatile oils, including wormwood oil, menthol and thymol
9.2 percent and water.
LABEL, IN PABT : "Amberin * * * Distributed Solely by The Amberin Com-
pany, Walla Walla, Washington."
NATURE OF CHARGE: Misbranding, Section 502 (a), the following statements in
the labeling were false and misleading since they represented and suggested
that the article would be effective for the treatment and cure of hemorrhoids,
whereas it would not be effective for that purpose: (Carton) "Hemorrhoids"
and (bottle label) "Hemorrhoids * * * Directions * * * Apply Am-
berin to a folded pad and affix to outside area, covering rectum * * * If
region is highly irritated or bleeding, you may experience a burning sensation
which passes quickly. External or protruding types react much quicker to
Amberin than other types. Amberin is ineffective in some types of itching
piles, but may give relief when basic cause is not allergy."
DISPOSITION : December 1, 1949. Default decree of condemnation. The court
ordered that the product be delivered to the Food and Drug Administration.