Crotan
Crotamiton
Marnel Pharmaceuticals, Inc.
Human Prescription Drug
NDC 0682-0051Crotan also known as Crotamiton is a human prescription drug labeled by 'Marnel Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Crotan is 0682-0051. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Crotan drug includes Crotamiton - 100 mg/g . The currest status of Crotan drug is Active.
Drug Information:
| Drug NDC: | 0682-0051 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Crotan |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Crotamiton |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Marnel Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CROTAMITON - 100 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 15 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA087204 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Marnel Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106219
2049603
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | D6S4O4XD0H
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0682-0051-10 | 237 g in 1 BOTTLE, PLASTIC (0682-0051-10) | 15 Jan, 2022 | N/A | No |
| 0682-0051-20 | 60 g in 1 BOTTLE, PLASTIC (0682-0051-20) | 15 Jan, 2022 | N/A | No |
| 0682-0051-30 | 454 g in 1 BOTTLE, PLASTIC (0682-0051-30) | 15 Jan, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Crotan crotamiton water mineral oil propylene glycol cetostearyl alcohol polyoxyl 20 cetostearyl ether cetyl alcohol lanolin benzyl alcohol carbomer homopolymer type a sodium hydroxide citric acid monohydrate crotamiton crotamiton
Drug Interactions:
Drug interactions: none known.
Indications and 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). image description
Indications and usage: for eradication of scabies ( sarcoptes scabiei ) and for symptomatic treatment of pruritic skin.
Warnings:
Warnings: if severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
Warnings and Cautions:
For topical use only. not for ophthalmic, oral or intravaginal use. rx only
Dosage and 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 se
Read more...cond 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.
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.
Drug Interactions:
Drug interactions: none known.
Use in 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.
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.
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.
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutangenesis, impairment of fertility: long-term carcinogenicity studies in animals have not been conducted.
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)
Information for Patients:
Information for patients: see "directions for patients with scabies."
Package Label Principal Display Panel:
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