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Pruradik ™ (crotamiton USP 10%) is a scabicidal and antipruritic agent as a lotion for topical use only. Crotamiton 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. Crotamiton is N-ethyl-N(o-methyl-phenyl) 2-butenamide and its structural formula is: Pruradik lotion contains crotamiton USP 10% (100mg/ml) in a creamy lotion base containing purified water, light mineral oil, propylene glycol, cetearyl alcohol (and) cetearth-20, cetyl alcohol, lanolin, benzyl alcohol, carbomer 971P, sodium hydroxide with citric acid (for pH adjustment). image description INDICATIONS AND USAGE: For eradication of scabies ( Sarcoptes scabiei ) and for symptomatic treatment of pruritic skin.

CLINICAL PHARMACOLOGY: Pruradik ™ lotion has scabicial 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.

Geriatric Use: Clinical studies with Pruradik (crotamiton USP) lotion 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.

ADVERSE REACTIONS: Primary irritation reactions such as dermatitis, pruritus and rash, and allergic sensitivity reactions have been reported in a few patients. To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma, LLC at 1-888-927-5191 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE: There is no specific informaton 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: SHAKE WELL BEFORE USE. 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 Pruritis: Massage gently into affected areas until medication is completely absorbed. Repeat as needed. DIRECTIONS FOR PATIENTS WITH SCABIES: 1. Take a routine bath or shower. Thoroughly massage Pruradik ™ lotion into the skin from the chin to the toes including folds and creases. 2. Put Pruradik lotion under fingernails after trimming the fingernails short, because scabies are likely to remain there. A toothbrush can be used to apply the Pruradik lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the brush in the mouth could lead to poisoning. 3. A second application is advisable 24 hours leater. 4. 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 washing machine. 5. A cleansing bath should be taken 48 hours after the last application.

PRECAUTIONS: General: Pruradik 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 acute inflammation has subsided.

Pregnancy (Category C): Animal reproduction studies have not been conducted with Pruradik (crotamiton USP) lotion. It is also not known whether Pruradik can cause fetal harm when applied to a pregnant woman or can affect reproduction capacity. Pruradik should be given to a pregnant woman only if clearly needed.

DESCRIPTION Eurax (crotamiton, USP) is a scabicidal and antipruritic agent available as a cream for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton, USP, in a vanishing-cream base containing: carbomer homopolymer type B, cetyl alcohol, diazolidinyl urea, dimethicone, glyceryl monostearate, laureth-23, magnesium aluminum silicate, benzyl alcohol, petrolatum, propylene glycol, sodium hydroxide, steareth-2, and water. Crotamiton is N-ethyl-N-( o -methylphenyl)-2-butenamide and its structural formula is: Crotamiton, USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is soluble with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203.28. structurenew

CLINICAL PHARMACOLOGY 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.

PRECAUTIONS General Do not apply Eurax in the eyes or mouth because it may cause irritation. Do not apply on acutely inflamed skin or raw or weeping surfaces until the acute inflammation has subsided. Information for Patients See DIRECTIONS FOR PATIENTS WITH SCABIES. Drug Interactions None known. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in animals have not been conducted. Pregnancy 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. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies with Eurax (crotamiton, USP) 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.

Pregnancy 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.

Geriatric Use Clinical studies with Eurax (crotamiton, USP) 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.

OVERDOSAGE 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. Change clothing and bed linen the next morning. Take a cleansing bath 48 hours after the last application. In Pruritus: Massage gently into affected areas until medication is completely absorbed. Repeat as needed. DIRECTIONS FOR PATIENTS WITH SCABIES: Take a routine bath or shower. Thoroughly massage Eurax cream into the skin from the chin to the toes including folds and creases. Put Eurax cream 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 under the fingernails. Immediately after use, wrap the toothbrush in paper and throw it 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 is sufficient for two applications. Change clothing and bed linen the next day. Dry clean contaminated clothing and bed linen, or wash in the hot cycle of the washing machine. Take a cleansing bath 48 hours after the last application.

DIRECTIONS FOR PATIENTS WITH SCABIES: Take a routine bath or shower. Thoroughly massage Eurax cream into the skin from the chin to the toes including folds and creases. Put Eurax cream 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 under the fingernails. Immediately after use, wrap the toothbrush in paper and throw it 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 is sufficient for two applications. Change clothing and bed linen the next day. Dry clean contaminated clothing and bed linen, or wash in the hot cycle of the washing machine. Take a cleansing bath 48 hours after the last application.

HOW SUPPLIED Eurax ® (crotamiton, USP) Cream, 10% is a white to yellowish-white soft cream and supplied as: 60 g tube NDC 69489-311-60 Store at room temperature, 20˚C - 25˚C (68˚F - 77˚F); Excursions permitted: 15˚C - 30˚C (59˚F - 86˚F) [See USP Controlled Room Temperature]. Keep out of reach of children. To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for: Journey Medical Corporation Scottsdale, AZ 85258 www.JMCderm.com EUR-P01-R00 Revised 12/2025 logo