CROTAN- crotamiton lotion

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Marnel Pharmaceuticals, Inc.

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. INDICATIONS AND USAGE:   For eradication of scabies ( Sarcoptes scabiei ) and for symptomatic treatment of pruritic skin. 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. Pediatric Use:  Safety and effectiveness in children have not been established.

Tuoteyhteenveto:

HOW SUPPLIED: CROTAN (crotamitan USP) lotion, 10% is available in: 60 gm ( NDC: 0682-0051-20) 237 gm ( NDC : 0682-0051-10) 454 gm ( NDC : 0682-0051-30) Rx ONLY Mfd For: Marnel Pharmaceuticals LLC Charleston, South Carolina USA 888-850-2905 Rev July 2021

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

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 greater
sensitivity of some older individuals cannot be ruled out.
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 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