FEDERAL SECURITY AGENCY
FOOD AND DRUG ADMINISTRATION ^sU^fj^
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
3141-3160
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 Federal
Security Agency.   Published by direction of the Federal Security Administrator.
PAUL B. DUNBAR, Commissioner of Food and Drugs.
WASHINGTON, D. C, November 1, 1950.
CONTENTS *
Page
Drugs actionable because of poten-
tial danger when used accord-
ing to directions 
 132
Drugs and devices actionable be-
cause of failure to bear ade-
quate   directions   or   warning
statements 
 132
Drugs actionable because of devia-
tion from official or own
standards 
  140
Drugs and devices actionable be-
cause of false and misleading
claims . 
 142
Drugs for human use 
 142
Drugs for veterinary use _.  146
Index 
 147
*For presence of a habit-forming narcotic without warning statement, see Nos. 3142-3144; omission of, or
unsatisfactory, ingredients statements, Nos. 3142, 3143,3145,3146; failure to bear a label containing an accu-
rate statement of the quantity of the contents, Nos. 3142-3147, 3159; failure to bear a label containing the
name and place of business of the manufacturer, packer, or^fetributor, Nos. 3142-3146; cosmetic, actionable
under the drug provisions of the Act, No. 3156. 
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DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DIRECTIONS 
3141. Misbranding of first aid kits.   U. S. v. 118 Kits    *    *    *.    (F. D. C. No.
29094.   Sample No. 80874-K.)
LIBEL FILED:   May 2, 1950, Eastern District of Pennsylvania.
ALLEGED SHIPMENT : On or about October 6, 1949, by the All State Iron Scrap
& Metal Co., from Middletown, Del.
PRODUCT : 118 first aid kits containing various items of .drugs including, in each,
an envelope of sulfanilamide powder (5 grams) and a package of 7.7 gr.
sulfadiazine tablets (8 tablets), at Philadelphia, Pa. Some of the kits con-
tained also a package of two tubes (?-ounce size) of tannic acid-sulfadiazine
ointment  (sulfadiazine 5?).
These products could not be used safely and efficaciously in self-medication.
They should be dispensed only on prescription, and they were in the hands of
a dealer who was not authorized to fill prescriptions.
NATURE OF CHARGE: Misbranding, Section 502 (j), the products were dangerous
to health when used in the dosage and with the frequency and duration pre-
scribed, recommended, and suggested in their labelings, as follows: (Sulfa-
nilamide powder) "For Topical Use Warning-Absorption of this drug ap-
plied locally varies with the tissue and degree of injury but may be sufficiently
great to cause systemic toxic reactions. Dyspnoea, vertigo, cyanosis, and
methemoglobinemia are signs that indicate a reduction of dosage. Constant
observation of the patient is essential. Caution: To be used only by or on
the prescription of a physician," (tannic acid-sulfadiasine ointment) "For
local application only not to be used on face, hands or genitals. Ointment
is removable with water or saline solution * * * for U. S. Army Use
Only," and (sulfadiazine tablets) "See back label for directions Caution-
To be used only by or on the prescription of a physician. Warning-This is
a dangerous drug which may cause serious or fatal injury unless taken under
adequate and continuous medical supervision. Directions 1. If wounded,
take two (2) tablets every five (5) minutes until all are taken. 2. It is im-
portant that you drink large quantities of water when taking the drug. 3. Cau-
tion-Do not take otherwise except under specific direction of Medical Officer."
DISPOSITION :   June 22, 1950.   Default decree of condemnation and destruction.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR
ADEQUATE DIRECTIONS OR WARNING STATEMENTS