6782. Entoquel with Neomycin syrup.    (F.D.C. No. 46219.    S. No. 76-752 R.)
QUANTITY :   68   6-oz. btls. at San Leandro, Calif.
SHIPPED :   3-1-61, from Kenilworth, N.J., by Wihite Laboratories, Inc.
LABEL IN PAST: "Entoquel with Neomycin Syrup Caution: * * * White 
Laboratories, Inc., Kenilworth, New Jersey Dosage: * * * Each Teaspoon 
(5 cc) contains * * * Thihexinol (Entoquel)-5 mg. Neomycin (from the 
sulfate)-50 mg.   Alcohol-0.5%."
ACCOMPANYING LABELING: A promotional form letter mailed on or about 
4-10-61, addressed to "Dear Doctor"; a promotional folder mailed on or 
about 4-27-61, entitled "Are opiates now outmoded in pediatric diarrhea ?"; 
and a promotional folder mailed in June or July 1961, entitled "Are opiates 
now outmoded in pediatric diarrhea?" with a picture of an infant and a bottle 
of paregoric on the cover.
LIBELED :    8-1-61, N. Dist. Calif.
CHARGE:   502(a)-when shipped and while held for sale, the labeling of the 
articles was false and misleading:
(1) in that the promotional form letter entitled "Dear Doctor" repre- 
sented that the drug would successfully treat diarrhea which threatened 
pediatric patients, without side effects, which representations were contrary 
to fact;
(2) in that the promotional folder mailed on or about April 27, 1961, 
represented that the drug "acts almost exclusively to inhibit gastro-intestinal 
motor function and does not interfere with gastric secretion, digestive proc- 
esses, or produce other undesirable atropine-like effects when given in the 
recommended dosage" and that "the only side effect noted was a mild, more 
or less transient flushing of the skin," which representations were contrary to 
fact; and
(3) in that the promotional folder entitled "Are opiates now outmoded 
in pediatric diarrhea?" with a picture of an infant and a bottle of paregoric 
on the cover, mailed in June or July 1961, represented that the article stopped 
diarrhea rapidly without side effects; that it did not interfere with gastric 
secretion, digestive processes, or produce other undesirable atropine-like 
effects, and that the sole side effect noted in the use of the drug was a mild 
flushing of the skin, which representations were contrary to fact;
502(f) (1)-the labeling of the article failed to bear adequate directions for 
use and it was not exempt from the requirement that the article bear such 
directions for use since the promotional material for the new drug was not 
the same as, or substantially the same as, the labeling authorized by the effec- 
tive new drug application; and 505(a)-the article was a new drug which 
may not be introduced or delivered for introduction into interstate commerce, 
since the effective new drug application filed with respect to the article did 
not apply to the conditions for which the article was promoted to the medical 
profession, namely,
(a) in a promotional form letter mailed to physicians on or about April 
10, 1961, addressed to "Dear Doctor," the drug was offered for the treatment 
of complications of severe pediatric diarrhea-dehydration, electrolyte im- 
balance, weight loss, pale, ashen skin, sunken fontanel, distended abdomen and 
constant crying; and
(b) in a promotional folder entitled "Are opiates now outmoded in pedi- 
atric diarrhea?" mailed to physicians on or about April 27,1961, the drug was 
offered for nonspecific digestive upsets and for nausea and vomiting, 
which labeling representations differed materially from the labeling claims 
permitted by the effective new drug application.
DISPOSITION :   9-21-61.   Default-destruction.
DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS