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Eurax
(crotamiton USP) Lotion/Cream
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIIC, 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: water, petrolatum, propylene glycol, steareth-2, cetyl alcohol, dimethicone, laureth-23, fragrance, magnesium aluminum silicate, carbomer-934, sodium hydroxide, diazolidinylurea, methylchloroisothiazolinone, methylisothiazolinone and magnesium nitrate. In addition, the cream contains glyceryl stearate. Crotamiton is N-ethyl-N-(o-methylphenyl) -2-butenamide and its structural formula is:
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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.
For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.
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:
Eurax (crotamiton USP)
Cream: 60g tubes (NDC 0072-2103-60; NSN 6505-00-116-0200).
Lotion: 60g (2 oz.) bottles (NDC 0072-2203-60, NSN 6505-01-153- 4423).
454g (16 oz.) bottles (NDC 0072-2203-16).
SHAKE WELL before using.
Store at room temperature.
Keep out of reach of children.
Westwood-Squibb Pharmaceuticals, Inc. A Bristol-Myers Squibb Company, Princeton, NJ 08543, USA. FDA Rev date: 6/26/2003
Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.
None known.
If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
Eurax (crotamiton cream, lotion) 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.
Long-term carcinogenicity studies in animals have not been conducted.
Animal reproduction studies have not been conducted with Eurax (crotamiton cream, lotion) . It is also not known whether Eurax (crotamiton cream, lotion) can cause fetal harm when applied topically to a pregnant woman or can affect reproduction capacity. Eurax (crotamiton cream, lotion) should be given to a pregnant woman only if clearly needed.
Safety and effectiveness in children 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.
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.
Eurax (crotamiton cream, lotion) 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.
Eurax (crotamiton cream, lotion) 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.
See DIRECTIONS FOR PATIENTS WITH SCABIES.
