1852. Adulteration and misbranding of atropine sulfate ointment and Nepco
Ammoniated Mercury Ointment, and misbranding of Nepco Ephedrine
Nasal Jelly and Nepco Sulfur Ointment. U. S. v. New England Pharma-
ceutical Corporation. Flea of guilty. Fine, $50 on each of 5 counts;
sentence suspended on count 6. (F. D. C. No. 17817. Sample Nos. 92835-F,
93003-F, 93701-F, 93703-F, 93707-F.)
INFORMATION FILED: April 12, 1946, Southern District of New York, against
the New England Pharmaceutical Corporation, New York, N. Y.
ALLEGED SHIPMENT: On or about January 17 and October 23, 1944, from the
State of New York into the District of Columbia and the. State of New Jersey.
PRODUCT : Analyses disclosed that various tubes of the atropine sulfate ointment
contained atropine sulfate in amounts varying from 0.46 percent to 2.60 per-
cent; that the nasal jelly contained approximately 1 percent of ephedrine
sulfate; that the ammoniated mercury ointment contained ammoniated mercury
corresponding to 8.4 percent of mercury; and that the sulfur ointment was of
U. S. P. strength.-
NATURE OF CHARGE: Atropine sulfate ointment. Adulteration, Section 501 (c),
the strength of the article differed from that which it purported and was
represented to possess, in that it was represented to contain 1 percent of
atropine sulfate, whereas some of the tubes of the article contained less
than 1 percent of atropine sulfate and other tubes contained more than 1
percent of atropine sulfate. Misbranding, Section 502 (a), the label state-
ment, "Atropine Sulfate 1?," was false and misleading.
Ephedrine nasal jelly. Misbranding, Section 502 (a), the label statement,
"For Head Colds, Etc., Subacute and Chronic Cases * * * used for relief
of inflammatory condition* of the Nose and Throat, such as Rhinitis, Laryn-
gitis, Common Cold, Hay Fever, especially in subacute and chronic cases,"
were false and misleading since the article would not be an adequate treat-
ment for head colds and other conditions suggested by the word "Etc."; it
would not be an adequate treatment for subacute and chronic cases of head
colds; and it would not be an adequate treatment for the relief of inflamma-
tory conditions of the nose and throat, rhinitis, laryngitis, common colds, and
hay fever, whether subacute and chronic or otherwise. Further misbranding,
Section 502 (f) (2), the article contained ephedrine and its label failed to
bear a warning that individuals suffering from high blood pressure^ heart
disease, diabetes, or thyroid trouble should not use the article except upon
competent advice; and its labeling also failed to warn that frequent or con-
tinued use of the article might cause nervousness, restlessness, or sleeplessness.
Ammoniated mercury ointment. Adulteration, Section 501 (b), the article
purported to be and was represented as a drug the name of which is recog-
nized in the United States Pharmacopoeia, an official compendium, but its
strength differed from the official standard in that it contained more than
4.5 percent of mercury, the maximum allowed by the standard, and its dif-
ference in strength from the standard was not plainly stated, or stated at all,
on its label. Misbranding, Section 502 (a), the label statements, "Ammoniated
Mercury Ointment U. S. P." and "Ammoniated Mercury U. S. P. XI," were
false and misleading since the article did not consist of ammoniated mercury
ointment that conformed to the requirements of the Pharmacopoeia. Further
misbranding, Section 502 (a), the label statement, "A stimulant and para-
siticide- in cutaneous eruptions, as scabies, ringworm, exzema and nprrigo,"
was false and misleading since it represented and suggested that the article
would be an adequate treatment for cutaneous eruptions such as scabies, ring-
worm, eczema, and porrigo, whereas it would not be an adequate treatment
for those conditions; Section 502 (f) (2), the labeling of the article failed
to bear a warning that application of the article to large areas of the body
might cause serious mercury poisoning; and, Section 502 (j), the article, be-
cause of its; content of mercury, would be dangerous to health when used in
the treatment of scabies in Hie dosage and with the frequency and duration
prescribed, recommended, and suggested in the labeling, "Directions Apply
with cotton or gauze on to affected parts."
Sulfur ointment. Misbranding, Section 502 (f) (1), the article was offered
for the treatment of scabies, and the directions for use in such treatment,
"Directions Apply directly to affected parts," appearing on the label of the
article, were not adequate directions for use in the treatment of scabies.
DISPOSITION: April 18, 1946. A plea of guilty having been entered on behalf
of the defendant, the court imposed a fine of $50 on each of counts 1 through
5 of the information and suspended sentence on count 6, which related to the
misbranding of the sulfur ointment.
NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION