FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act] j-V*"'*
4301-4320 
._ Y 
4^\
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district
courts by the United States attorneys, acting upon reports submitted by the
Department of Health, Education, and Welfare, and include, where indicated, the
results of investigations by the Department, prior to the institution of the pro-
ceedings. Published ,by direction of the Secretary of Health, Education, and
Welfare.
GEO. P. LABRICK, Commissioner of Food and Drugs.
WASHINGTON, D. C, February 18,1950.
CONTENTS
Page
Drug actionable because of poten-
tial danger when used accord-
ing to directions
284
Violative sales of prescription drugs. 284
Drugs and devices actionable be-
cause of failure to bear ade-
quate   directions   or   warning
statements
288
Page
Drugs actionable because of devia-
tion from official or own stand-
ards 
290
Drugs and devices actionable be-
cause of false and misleading
claims , 
291
Index  
 _ 295
329297-55-
283
DRUG ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DIRECTIONS
4301. Misbranding of vaginal suppositories.   U. S. v. 22 Boxes * * *.   CF. D. C.
No. 36219.   Sample No. 45306-L.)
LIBEL FILED :   December 30,1953. District of Rhode Island.
ALLEGED SHIPMENT: On or about July 3,1953, bv the Dr. ,T. A. McGill Co.. from
Chicago, 111.
PBODTJCT : 22 boxes of vaginal suppositories at Providence, R. I. Each box con-
tained a copy of a leaflet entitled "Dr J. A. McGill Co.'s Suppositories." Ex-
amination showed that each suppository weighed approximately 5.47 grams
and contained approximately 47 percent ammonium alum and 16 percent borax.
LABEL, IN PAST: (BOX) "Contents 6 Suppositories * * * Orange Blossom
Suppositories * * * Alum-Borax-Petrolatum * * * Dr. J. A. McGill Co. * * *
Chicago 16, 111."
NATURE OF CHARGE: Misbranding, Section 502 (a), the statement on the box
label and in the above-mentioned-leaflet, namely, "For Simple Irritations Of
The Vaginal Tract," was false and misleading. The statement represented
and suggested that the article was an adequate and effective treatment for
diseases of the vaginal tract which are manifested by irritation of the vaginal
tract, whereas the article was not an adequate and effective treatment for
these diseases.
Further misbranding, Section 502 (j), the article was dangerous to health
when used in the dosage and with the frequency and duration prescribed,
recommended, and suggested in its labeling, namely, "Directions Remove
tinfoil at bedtime, 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 supposi-
tory every five days."
DISPOSITION : January 25, 1954. Default decree of condemnation and destruc-
tion.
VIOLATP7E SALES OF PRESCRIPTION DRUGS