INDICATIONS AND USAGE: HALOG (Halcinonide, USP) Cream or Ointment 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
IMPORTANT SAFETY INFORMATION
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
This medication is to be used as directed by the physician. It is for dermatologic use only. Avoid contact with the eyes.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
Patients should report any signs of local adverse reactions especially under occlusive dressing.
Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
This preparation is not for ophthalmic, oral, or intravaginal use.
For topical use only. Please see Full Prescribing Information.
If you experience any Adverse Events you are encouraged to report them to the Drug Safety Department at 1-800-406-7984 or email Drug.Safety@ranbaxy.com. You can also report to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.