NDC 0682-0051 Crotan

Crotamiton

NDC Product Code 0682-0051

NDC CODE: 0682-0051

Proprietary Name: Crotan What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Crotamiton What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat scabies. Scabies is a skin infection caused by mites that burrow into the skin. Irritation from the mites leads to severe itching and small bumps/blisters filled with fluid/pus. Crotamiton works by killing the mites that cause scabies. It also helps relieve itching related to scabies and other skin conditions. Crotamiton belongs to two classes of drugs: scabicides and antipruritics.

NDC Code Structure

NDC 0682-0051-10

Package Description: 237 g in 1 BOTTLE, PLASTIC

NDC 0682-0051-20

Package Description: 60 g in 1 BOTTLE, PLASTIC

NDC 0682-0051-30

Package Description: 454 g in 1 BOTTLE, PLASTIC

NDC Product Information

Crotan with NDC 0682-0051 is a a human prescription drug product labeled by Marnel Pharmaceuticals, Inc.. The generic name of Crotan is crotamiton. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Marnel Pharmaceuticals, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Crotan Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CROTAMITON 100 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • LANOLIN (UNII: 7EV65EAW6H)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Marnel Pharmaceuticals, Inc.
Labeler Code: 0682
FDA Application Number: ANDA087204 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-16-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Crotan Product Label Images

Crotan Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Warnings And Precautions

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

Indications & 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).

INDICATIONS AND USAGE:  For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.

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.

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.

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.

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.

Dosage & 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 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:  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.

Warnings

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

Precautions

PRECAUTIONS:  General:  CROTAN 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."

Drug Interactions

Drug Interactions:  None known.

Carcinogenesis & Mutagenesis & 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 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.

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)

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Storage And Handling

STORAGE:  Store 20° to 25ºC (68° - 77°F).  Excursions allowed between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature].

* Please review the disclaimer below.