4581. Vaginal suppositories.    (Inc. No. 279.)
COMPLAINT FOR INJUNCTION FILED: 5-20-54, N. Dist. Ill., against Harriet Me- 
rrill Flickinger, Pa Dr. J. A. Mill Co., Not Inc., and Clara H. Nielsen, gen- 
eral manager of the business, to enjoin the interstate shipment of the above- 
mentioned article.
LABEL IN PART: (BOX) "Contents 6 Suppositories Orange Blossom Supposi- 
tories Active Ingredients of Each Suppository: Alum—Borax—Petrolatum 
Prepared by DR. J. A. McGDLL CO., Not Inc. 2001-3 Indiana Ave., Chicago 
16, Ill. For Simple Irritations Of The Vaginal Tract Directions—Remove 
tinfoil and at bed time insert one suppository in vagina and with your 
finger push it up as far as you can. Let it remain there undisturbed for 
three days. Then at night take a douche of warm water, and on the evening 
of the second day apply again as above, making the application every five 
days excepting at monthly periods, allowing four days for the periods, then 
apply the suppository every .five days. The use of Orange Blossom Supposi- 
tories is not recommended at the menstrual period or during pregnancy."
ACCOMPANYING LABELING :   Leaflet entitled "Dr. J. A. Mill Co.'s Suppositories."
CHARGE: The complaint alleged that the article, when used as a suppository 
in the vagina in the manner recommended in its labeling, or in any other 
dosage, was unsafe and dangerous to health and that the article, because of 
its alum content, may cause serious injury by destroying normal, healthy 
tissue in the vaginal tract and that the defendants had been and still were 
engaged in preparing, selling, and introducing into interstate commerce such 
article which was misbranded under 502 (a), and that its labeling, when con-
sidered in its entirety and in the setting in which it was used, created the 
false and misleading impression that the article was a safe, adequate, and 
effective treatment for simple irritations of the vaginal tract; and under 
502 (j), in that the article was dangerous to health when used in the dosage 
and with the frequency and duration prescribed, recommended, and suggested 
in its labeling.
The complaint further alleged that if the defendants were forced by an 
injunction to refrain from using the existing labeling on interstate shipments 
of the article, the defendants would not discontinue interstate distribution of 
the article but would, unless enjoined, continue to ship the article in interstate 
commerce without labeling stating the dosage for the article and without 
labeling stating the conditions and purposes for which the article was intended; 
and that, in such case, the article would be misbranded under 502 (f) (1), 
in that its labeling would fail to bear adequate directions for use because of 
the omission from its labeling of the dosage for the article and because of the 
omission from its labeling of statements of the conditions and purposes for 
which the article was intended.
DISPOSITION : 12-23-54. The defendants having consented, the court entered a 
decree of injunction perpetually enjoining the defendants from introducing into 
interstate commerce the article, or any other article of similar composition, 
which was misbranded under 502 (a), 502 (f)  (1), and 502 (j).