ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS: Primary inrritation reactions such as dermititis, pruritus and rash, and allergic sensitivity reactions have been reported in few patients. To report SUSPECTED ADVERSE REACTIONS, contact Marnel Pharmaceuticals at 1-888-850-2905 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutangenesis, Impairment of Fertility: Long-term carcinogenicity studies in animals have not been conducted.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY: CROTAN (TM) 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS: CROTAN lotion should not be applied topically to patients who develop sensitivity or are allergic to it or who manifest primary irritation response to topical medications.

DOSAGE & ADMINISTRATION SECTION.

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. second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. 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 routine bath or shower. Thoroughly massage CROTAN (TM) lotion into the skin from the chin to the toes including folds and creases. 2. Put CROTAN lotion under fingernails after trimming the fingernails short, because scabies are likely to remain there. toothbrush can be used to apply the CROTAN 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 lead poisoning.3. 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. cleansing bath should be taken 48 hours after the last application.

GERIATRIC USE SECTION.

Geriatric Use: Clinical studies with CROTAN (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 great sensitivity of some older individuals cannot be ruled out.

INDICATIONS & USAGE SECTION.

CROTAN (TM) (crotamiton USP 10%) is scabicidal and antipruritic agent as lotion for topical use only. Crotamiton is colorless to slightly yellowish oil, having faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is 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: CROTAN lotion contains crotamiton USP 10% (100mg/ml) in 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.

OVERDOSAGE SECTION.

OVERDOSAGE: There is no specific informaton on the effect of overtreatment with repeated topical applications in humans. 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.

PRECAUTIONS SECTION.

P RECAUTIONS: General: CROTAN 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 SECTION.

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