Get your patient on Crotan - Crotamiton lotion (Crotamiton)

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).

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 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: 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.

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

Rx ONLY

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 Marnel Pharmaceuticals at 1-888-850-2905 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions: None known.

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.

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

60 gm ( NDC: 0682-0051-20)

237 gm ( NDC : 0682-0051-10)

454 gm ( NDC : 0682-0051-30)

Rx ONLY

Mfd For:

Marnel Pharmaceuticals LLC

Charleston, South Carolina USA

888-850-2905

Rev July 2021