Official product label reference
Pruradik — Trifluent Pharma, LLC
This page contains 18 source sections for CROTAMITON, topical route. Label set 3699175f-bfc8-a047-e063-6394a90a80d1, version 1.
Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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. 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: Pruradik 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). image description
INDICATIONS AND USAGE: For eradication of scabies ( Sarcoptes scabiei ) and for symptomatic treatment of pruritic skin.
Dosage and administration — label text
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 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.
Contraindications
CONTRAINDICATIONS: 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.
Warnings and precautions
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Rx ONLY
Warnings
WARNINGS: If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
Adverse reactions
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 Trifluent Pharma, LLC at 1-888-927-5191 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Drug Interactions: None known.
Clinical pharmacology
CLINICAL PHARMACOLOGY: Pruradik ™ 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.
Older adults
Geriatric Use: 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.
Overdose information
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.
Precautions
PRECAUTIONS: General: Pruradik 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."
Carcinogenesis and mutagenesis and 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 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.
Children and adolescents
Pediatric Use: Safety and effectiveness in children have not been established.
Supply and packaging
HOW SUPPLIED: 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
Child safety
KEEP OUT OF REACH OF CHILDREN.
Storage and handling
STORAGE: Store 20 ° to 25 º C (68 ° - 77 ° F). Excursions allowed between 15 ° and 30 ° C (59 ° and 86 ° F) [See USP Controlled Room Temperature].
Official sources and product identifiers
- DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
- openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
- Drugs@FDA application ANDA087204Application history where available; verify the specific product and indication.
Substances listed: CROTAMITON
RxNorm identifiers: 106219
Package NDC codes
73352-051-10
Further research and background
These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.
Coverage and corrections
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.
Source retrieved 2026-10-02. Read the source policy.