Label: CROTAN- crotamiton lotion

  • NDC Code(s): 0682-0051-10, 0682-0051-20, 0682-0051-30
  • Packager: Marnel Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 14, 2021

If you are a consumer or patient please visit this version.

  • 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:

    image description

    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).

  • 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.

  • INDICATIONS & USAGE

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

  • 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

    P RECAUTIONS:  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)

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CROTAN 
    crotamiton lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0682-0051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CROTAMITON (UNII: D6S4O4XD0H) (CROTAMITON - UNII:D6S4O4XD0H) CROTAMITON100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0682-0051-10237 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2022
    2NDC:0682-0051-2060 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2022
    3NDC:0682-0051-30454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08720401/15/2022
    Labeler - Marnel Pharmaceuticals, Inc. (080161449)
    Registrant - Marnel Pharmaceuticals, Inc. (080161449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Groupe Parima252437850manufacture(0682-0051) , pack(0682-0051)