ward off Eurax Generic Name: crotamiton Dosage Form: cream, lotion Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Pricing & Coupons Eurax (crotamiton, USP) Lotion/Cream (10% w/w) FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE Rx only Slideshow Insomnia and Sleep Deprivation: The Case For A Good Night's Sleep Eurax Description 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 formula is: 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 - 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. Indications and Usage for Eurax For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin. Contraindications 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. Warnings If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted. Precautions General 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. Information for Patients See DIRECTIONS FOR PATIENTS WITH SCABIES Drug Interactions None known. Carcinogenesis and Mutagenesis and 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. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use 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. Adverse Reactions Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients. 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. Eurax 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 washing machine. A cleansing bath should be taken 48 hours after the last application How is Eurax Supplied Eurax (crotamiton, USP) Cream, 10% is a white to yellowish-white soft cream with a perfumed characteristic odor and supplied as: 60 g tubes NDC 10631-091-60 (NSN 6505-00-116-0200) Eurax (crotamiton, USP) Lotion, 10% is a white to yellowish-white lotion having a characteristic perfumed odor and supplied as: 60 g (2 oz.) bottle NDC 10631-092-60 (NSN 6505-01-153-4423) 454 g (16 oz.) bottle NDC 10631-092-16 SHAKE WELL before using. Store at room temperature. Keep out of reach of children. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. RANBAXY Jacksonville, FL 32257 USA 129845 September 2012 Eurax Cream Eurax Cream 60 g Tube Eurax Cream 60 g Tube Eurax Cream 60 g Tube Eurax Cream 60 g Tube Eurax Cream 60 g Carton Eurax Lotion Eurax Lotion 60 g (2 oz.) label Eurax crotamiton cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10631-091 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CROTAMITON (CROTAMITON) CROTAMITON 100 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL DIAZOLIDINYL UREA CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) LAURETH-23 MAGNESIUM NITRATE METHYLCHLOROISOTHIAZOLINONE STEARETH-2 GLYCERYL MONOSTEARATE DIMETHICONE MAGNESIUM ALUMINUM SILICATE METHYLISOTHIAZOLINONE PETROLATUM PROPYLENE GLYCOL SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:10631-091-60 1 TUBE in 1 CARTON 1 60 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA006927 12/15/2008 Eurax crotamiton lotion Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10631-092 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CROTAMITON (CROTAMITON) CROTAMITON 100 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL DIAZOLIDINYL UREA CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) LAURETH-23 MAGNESIUM NITRATE METHYLCHLOROISOTHIAZOLINONE STEARETH-2 GLYCERYL MONOSTEARATE DIMETHICONE MAGNESIUM ALUMINUM SILICATE METHYLISOTHIAZOLINONE PETROLATUM PROPYLENE GLYCOL SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:10631-092-60 60 g in 1 BOTTLE 2 NDC:10631-092-16 454 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA009112 11/13/2008 Labeler - Ranbaxy Laboratories Inc. (169932519) Registrant - Ranbaxy Laboratories Inc. (169932519) Establishment Name Address ID/FEI Operations DPT Laboratories, Ltd 832224526 MANUFACTURE(10631-091, 10631-092), PACK(10631-091, 10631-092) Revised: 01/2015 Ranbaxy Laboratories Inc. Next Pregnancy Warnings Print this page Add to My Med List More about Eurax (crotamiton topical) Side Effects During Pregnancy Dosage Information Support Group Pricing & Coupons En Español 2 Reviews Add your own review/rating Generic Availability Drug class: topical anti-infectives Consumer resources Eurax ... +3 more Professional resources Eurax (AHFS Monograph) Related treatment guides Pruritus Scabies} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Topical anti-infectives Related Drugs topical anti-infectives ivermectin topical , imiquimod topical , permethrin topical , Aldara , Elimite , Abreva Scabies permethrin topical , Elimite , lindane topical , Acticin , Nix Cream Rinse , crotamiton topical , Lice Bedding Spray , More... Pruritus hydroxyzine , lidocaine topical , hydrocortisone topical , diphenhydramine , Benadryl , doxepin topical , Vistaril , Atarax , cyproheptadine , Anusol-HC , Proctosol-HC , More... Eurax Rating 2 User Reviews 7.8 /10 2 User Reviews 7.8 Rate it!} } bargain
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