Crotamiton

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

• Pruradik ™ (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.

• 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.contraindicated

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 Pruradik ™ lotion into the skin from the chin to the toes including folds and creases. 2. Put 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. A cleansing bath should be taken 48 hours after the last application.

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

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 Trifluent Pharma, LLC at 1-888-927-5191 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy (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.

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.

• Jul 6, 1949NDANDA006927Journey
• Dec 16, 1981ANDAANDA087204Legacy Pharma

1. 1Pruritus6110%
2. 2Rash447.2%
3. 3Pyrexia315.1%
4. 4Malaise274.4%
5. 5Anaemia264.3%
6. 6Pain264.3%
7. 7Hepatic Function Abnormal254.1%
8. 8Diarrhoea213.5%
9. 9Erythema213.5%
10. 10Pneumonia213.5%
11. 11Urticaria203.3%
12. 12Rash Pruritic193.1%
13. 13Vomiting193.1%
14. 14Constipation183.0%
15. 15Decreased Appetite183.0%

Frequently asked questions

How does Crotamiton work?

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

What is Crotamiton used for?

According to FDA labeling, Crotamiton carries indications including: Pruradik ™ (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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Crotamiton?

Crotamiton is classified as Unknown Cellular or Molecular Interaction.

What are the brand names for Crotamiton?

Crotamiton is marketed under brand names including Crotan, Eurax.

What are the contraindications for Crotamiton?

Crotamiton labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.