FOR TOPICAL USE ONLY NOT
FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
Eurax (crotamiton USP) is a scabicidal and antipruritic agent available
as a cream or lotion for topical use only. Eurax provides 10% (w/w) of the
synthetic, crotamiton USP, in a vanishing-cream or emollient-lotion base containing:
carbomer-934, cetyl alcohol, diazolidinylurea, dimethicone, fragrance, laureth-23,
magnesium aluminum silicate, magnesium nitrate, methylchloroisothiazolinone,
methylisothiazolinone, petrolatum, propylene glycol, sodium hydroxide, steareth-2,
and water. In addition, the cream contains glyceryl stearate. Crotamiton is
N-ethyl-N-(o-methylphenyl)-2-butenamide and its structural
Crotamiton USP is a colorless to slightly yellowish oil, having
a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton
is a mixture of the cis and trans isomers.
Its molecular weight is 203.28.
Eurax has scabicidal and antipruritic actions. The mechanisms of
these actions are not known. The pharmacokinetics of crotamiton and its degree
of systemic absorption following topical application have not been determined.
INDICATIONS AND USAGE
For eradication of scabies (Sarcoptes scabiei) and
for symptomatic treatment of pruritic skin.
Eurax should not be applied topically to patients who develop a
sensitivity or are allergic to it or who manifest a primary irritation response
to topical medications.
If severe irritation or sensitization develops, treatment with
this product should be discontinued and appropriate therapy instituted.
Eurax should not be applied in the eyes or mouth because it may
cause irritation. It should not be applied to acutely inflamed skin or raw
or weeping surfaces until the acute inflammation has subsided.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in animals have not been conducted.
Pregnancy (Category C)
Animal reproduction studies have not been conducted with Eurax.
It is also not known whether Eurax can cause fetal harm when applied topically
to a pregnant woman or can affect reproduction capacity. Eurax should be given
to a pregnant woman only if clearly needed.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies with Eurax (crotamiton USP) Lotion/Cream did not
include sufficient numbers of subjects aged 65 years and older to determine
whether they respond differently than younger subjects. Other reported clinical
experience has not identified differences in responses between elderly and
younger patients, but greater sensitivity of some older individuals cannot
be ruled out.
Primary irritation reactions, such as dermatitis, pruritus, and
rash, and allergic sensitivity reactions have been reported in a few patients.
There is no specific information on the effect of overtreatment
with repeated topical applications in humans. A death was reported but cause
was not confirmed.
Accidental oral ingestion may be accompanied by burning sensation
in the mouth, irritation of the buccal, esophageal and gastric mucosa, nausea,
vomiting, abdominal pain.
If accidental ingestion occurs, call your Poison Control Center.
DOSAGE AND ADMINISTRATION
In Scabies: Thoroughly massage into the skin
of the whole body from the chin down, paying particular attention to all folds
and creases. A second application is advisable 24 hours later. Clothing and
bed linen should be changed the next morning. A cleansing bath should be taken
48 hours after the last application.
In Pruritus: Massage gently into affected areas
until medication is completely absorbed. Repeat as needed.
LOTION: Shake well before using.
DIRECTIONS FOR PATIENTS WITH SCABIES:
Take a routine bath or shower. Thoroughly massage Eurax cream or
lotion into the skin from the chin to the toes including folds and creases.
Put Eurax cream or lotion under fingernails after trimming the fingernails
short, because scabies are very likely to remain there. A toothbrush can be
used to apply the Eurax cream or lotion under the fingernails. Immediately
after use, the toothbrush should be wrapped in paper and thrown away. Use
of the same brush in the mouth could lead to poisoning.
A second application is advisable 24 hours later.
A 60 gram tube or bottle is sufficient for two applications.
Clothing and bed linen should be changed the next day. Contaminated
clothing and bed linen may be dry-cleaned, or washed in the hot cycle of the
A cleansing bath should be taken 48 hours after the last application.
Eurax® (crotamiton USP)
60 g tubes
NDC 0072-2103-60 (NSN 6505-00-116-0200)
60 g (2 oz.) bottles
NDC 0072-2203-60 (NSN 6505-01-153-4423)
454 g (16 oz.) bottles
SHAKE WELL before using.
Store at room temperature.
Keep out of reach of children.
Distributed by: Westwood-Squibb Pharmaceuticals,
Inc. A Bristol-Myers Squibb Company Princeton, NJ 08543
51-030139-01 Revised April 2006
HUMAN PRESCRIPTION DRUG
Item Code (Source)
Route of Administration
Name (Active Moiety)
crotamiton (crotamiton )
100 MILLIGRAM In 1 GRAM
magnesium aluminum silicate
contains a TUBE
This package is contained within the CARTON (0072-2103-60)