CROTAN- crotamiton lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CROTAMITON (UNII: D6S4O4XD0H) (CROTAMITON - UNII:D6S4O4XD0H)

Available from:

Marnel Pharmaceuticals, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). 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 resp

Product summary:

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)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CROTAN- CROTAMITON LOTION
MARNEL PHARMACEUTICALS, INC.
----------
CROTAN LOTION
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL
USE.
RX ONLY
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).
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: 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: 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: 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