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Cormax

Watson Pharma, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Cormax® Ointment 0.05% (Clobetasol Propionate Ointment, USP)

Rx only
For Dermatologic Use Only - Not for Ophthalmic Use.

CORMAX DESCRIPTION




Cormax25325

CLINICAL PHARMACOLOGY



Pharmacokinetics

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION






CORMAX INDICATIONS AND USAGE



CORMAX CONTRAINDICATIONS


PRECAUTIONS

General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g per day.






PRECAUTIONS: Pediatric Use








Information for Patients


  • This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only Avoid contact with the eyes.
  • This medication should not be used for any disorder other than that for which it is prescribed.
  • The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.
  • Patients should report any signs of local adverse reactions to the physician.

Laboratory Tests



Carcinogenesis, Mutagenesis, Impairment of Fertility



Pregnancy

Teratogenic Effects: Pregnancy Category C:

Nursing Mothers


not

Pediatric Use



Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.


Geriatric Use

CORMAX ADVERSE REACTIONS



OVERDOSAGE

PRECAUTIONS

CORMAX DOSAGE AND ADMINISTRATION



treatment must be limited to two consecutive weeks, and amounts greater than 50 g per week should not be used, Cormax Ointment is not to be used with occlusive dressings.

HOW SUPPLIED



Rx only

Keep out of reach of children












Principal Display Panel

New NDC#
NDC 52544-048-89      45g Tube
Cormax Ointment 0.05%
(Clobetasol Propionate Ointment, USP)
Watson      Rx Only

CormaxCormax


Cormax

clobetasol propionate OINTMENT

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52544-048
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE clobetasol 0.5 mg

Inactive Ingredients

Ingredient Name Strength
propylene glycol
petrolatum

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 TUBE
2 45 in 1 TUBE
3 NDC:52544-048-89 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074221 2008-09-18


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Be sure to consult your doctor before taking any medication!
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