FDA Label for Crotan

Warnings And Precautions

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

Rx ONLY

Indications & Usage

CROTAN ^™ (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:

CROTAN 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).

INDICATIONS AND USAGE:  For eradication of scabies ( Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.

Clinical Pharmacology

CLINICAL PHARMACOLOGY:  CROTAN ^™ 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

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.

Adverse Reactions

ADVERSE REACTIONS:  Primary inrritation reactions such as dermititis, pruritus and rash, and allergic sensitivity reactions have been reported in a 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.

Overdosage

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 & Administration

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 CROTAN ^™ 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.  A 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.  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.

Contraindications

CONTRAINDICATIONS:  CROTAN 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.

Warnings

WARNINGS:  If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.

Precautions

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.

Information For Patients

Information for Patients:  See "DIRECTIONS FOR PATIENTS WITH SCABIES."

Drug Interactions

Drug Interactions:  None known.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

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

Pregnancy

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 a pregnant woman or can affect reproduction capacity.  CROTAN should be given to a pregnant woman only if clearly needed.

Pediatric Use

Pediatric Use:  Safety and effectiveness in children have not been established.

How Supplied

HOW SUPPLIED:  CROTAN (crotamitan USP) lotion, 10% is available in:

2 fl oz ( NDC 0682-0051-20)

8 fl oz ( NDC 0682-0051-10)

16 lf oz ( NDC 0682-0051-30)

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Storage And Handling

STORAGE:  Store 20 ^° to 25 ^°C (68 ^° - 77 ^°F).  Excursions allowed between 15 ^° and 30 ^°C (59 ^° and 86 ^°F) [See USP Controlled Room Temperature].