3621.
115
996670-52-
USED ACCORDING TO DIRECTIONS
/562^.*Afliirt^ration and misbranding of ear wax drops and Alom Jel and mis-
bfcaji&ng of Vita-Malt, Eph-Thol nose drops, Pyrinimate, Pyrinimate
tablets, hydrogen peroxide, milk of magnesia, and calamine lotion. U. S.
v. 10,000 Bottles, etc (P. D. C. No. 31639. Sample Nos. 18271-L to
18280-L, incl.)
LIBEL FILED :    August 23,1951, District of Arizona.
ALLEGED SHIPMENT: On or about May 7, 8, 14, 17. 18, 21, and 28, 1951, from
Burbank and Los Angeles, Calif. The products were snipped to Phoenix, Ariz.,
and with the exception of the VitarMalt, were either labeled or repacked and
labeled while held for sale after such shipment.
PRODUCT : 10,000 bottles of Vita-Malt; 21 cases, each containing 48 bottles, of.
Eph-Thol nose drops; 11 cases, each containing 48 bottles, or ear wax drops;
53 cases, each containing 24 bottles, of Alom Jel; 98 bottles of Pyrinimate; 1
drum containing 25,000 25 mg. Pyrinimate tablets and 1 drum containing
25,000 50 mg. Pyrinimate tablets; 12 cases, each containing 24 bottles, of
hydrogen peroxide; 17 cases, each containing 4 bottles, of milk of magnesia;
and 8 bottles of calamine lotion.
Analysis showed that the Eph-Thol nose drops consisted of an aqueous solu-
tion containing 0.99 percent ephedrine sulfate, chlorobutanol (a chloral deriva-
tive), and a small proportion of menthol; that the ear wax drops contained
approximately 4.8 percent phenol; that the Alom Jel contained 2.32 percent of
aluminum oxide in the form of aluminum hydroxide and hydrated oxide (the
United States Pharmacopeia provides that aluminum hydroxide gel shall eon-
tain not less than 3.6 percent of aluminum oxide in the form of aluminum
hydroxide and hydrated oxide) ; that the Pyrinimate and the Pyrinimate
tablets contained pyrilamine maleate, with the 50-milligram tablet containing
approximately 41.5 milligrams of pyrilamine maleate per tablet; that the
hydrogen peroxide was short volume; and that the calamine lotion contained
glycerin and lime water, ingredients not specified in the formula for this article
as set forth in the currently official United States Pharmacopeia, and did not
contain polyethylene glycol 400 monostearate which is specified as an ingredient
of the formula in the currently official United States Pharmacopeia.
LABEL, IN PART: "1 Lb. Size RC Vita-Malt Standardized," "RC Eph-Thol
(Ephedrine Menthol) Nose Drops One Ounce," "RC Ear Wax Drops One
Ounce Phenol 1? and Glycerine," "One Pint RC Alom Jel Aluminum
Hydroxide Gel," "One Pt RC Hydrogen Peroxide," "One Gal. RC Milk of
Magnesia U. S. P.," and "One GaL RC Calamtn^tsotian UJ&P..: .Packaged
By Contract For R & C Co., Nutley, N. J.," and "R & C Pyrinimate Anti-Hista-
mine Pyrinilamine Maleate 2.5 mg.' Suerose - Glycerine [or "R & C Pyrini-
mate Tablets Anti-Histamme Pyrinilamine Maleate 25 mg. [or 50 mg.]]
Packed by Contract For R & C Co., Nutley, N. J."
NATURE OF CHARGE: Adulteration, Section 501 (b), the Alom Jel purported to
be and was represented as "Aluminum Hydroxide Gel," a drug, the name of
which is recognized in the United States Pharmacopeia, an official compendium,
and its strength differed from that set forth in such compendium; and, Sec-
tion 501 (c), the strength of the ear wax drops differed from that which it was
represented to possess, namely, phenol 1 percent.
bear the name and place of business of the manufacturer, packer, or distribu-
tor. (There was no It & C Co. of Nutley, N. J., as declared upon the labels
of the articles.)
Further misbranding, Section 502 (a),-the label statement I'Pyrinilamine 4 r    f
Maleate 50 mg." on the label of a portion of the Pyrinimate tablets was false >
and misleading as applied to an article containing less than 50 mg. of pyrila-
mine maleate, and the label designation "U. S. P." on the label of the calamine
lotion was false and misleading as applied to an article, the identity of which
differed from that listed in the current revision of the United States Pharma-
copeia; and, Section 502 (b) (2), the hydrogen peroxide tailed to bear a label
containing an accurate statement of the quantity of the contents.
"\ Further misbranding, Section 502 (d), the EpJi-Thol nose drops contained a
chemical derivative of chloral, namely, chlorobutanol, which derivative has
been found to be and by regulations designated as, habit forming; and the label
of the article failed to bear the name, and quantity or proportion of such
derivative and in juxtaposition therewith the statement "Warning-May be
habit forming."
Further misbranding, Section 502 (e) (2), the label of the Eph-Thol nose
drops failed to bear the common or usual name of each active ingredient since
ephedrine sulfate was. not declared, and the label of the Pyrinimate and the
Pyrinimate tablets failed to bear the common or usual name of each active
ingredient since pyrilamine maleate was not declared; and, Section 502 (j),
the ear wax drops were dangerous to health when used in the dosage prescribed
in the labeling.
The articles were adulterated and misbranded as described above while held
for sale after shipment in interstate commerce.
DISPOSITION: On or about November 29, 1951, the Kimball Drug Co., Phoenix,
Ariz., having appeared as claimant, judgment of condemnation was entered
and the court ordered that the products be released under bond for reprocess-
ing and relabeling to comply with the law, under the supervision of the Federal
Security Agency.