E-RAX

Crotamiton is a scabicidal and antipruritic agent available as a cream or lotion for topical use only.

It is a colorless to slightly yellowish oil, having a faint amine-like odor.

It is miscible with alcohol and with methanol.

For eradication of scabies ( Sarcoptes scabiei ) and for symptomatic treatment of pruritic skin.

Crotamiton is usually used to treat pruritis (itching of the skin) caused by scabies or sunburn.

Crotamiton relieves itching by producing what is called a counter-irritation.

As crotamiton evaporates from the skin, it produces a cooling effect.

This cooling effect helps to divert your body's attention away from the itching.

Due to this cooling effect it is also effective for the relief of sunburn.

The drug is also believed to kill scabies through an unknown mechanism.

Transient receptor potential cation channel subfamily

V member 4 Inhibitor.

% absorbed when applied locally.

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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.

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

Pruradik 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.

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.

Massage gently into affected areas until medication is completely absorbed.

Repeat as needed.

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.

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.

Pruradik (crotamitan USP) lotion, 10% is available in: 237 gm ( NDC: 73352-051-10) Rx ONLY Mfd For: Trifluent Pharma, LLC San Antonio TX 78213 Rev 01 May 2025.

Store 20 ° to 25 º C (68 ° - 77 ° F).

Excursions allowed between 15 ° and 30 ° C (59 ° and 86 ° F) .

(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.

Safety and effectiveness in children have not been established.

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.