Halcinonide (Page 2 of 2)

ADVERSE REACTIONS

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.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS: General).

DOSAGE AND ADMINISTRATION

Apply the 0.1% halcinonide cream to the affected area two to three times daily. Rub in gently.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply halcinonide cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Halcinonide Cream USP, 0.1% is supplied as:
NDC 71428-011-30 Tubes containing 30 g of cream
NDC 71428-011-60 Tubes containing 60 g of cream

Storage

Store at room temperature; avoid excessive heat (104° F).

To report SUSPECTED ADVERSE REACTIONS, contact Glasshouse Pharmaceuticals Limited Canada at 1-833-284-1788 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:
Glasshouse Pharmaceuticals Limited Canada
Mississauga, Ontario, Canada L5N 6R8

Revised: October 2020

Halcinonide Cream USP, 0.1%

Rx Only

For Topical Use Only. Not for Ophthalmic, Oral or Intravaginal Use.

NDC 71428-011-60

HALCINONIDE halcinonide cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71428-011 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALCINONIDE (HALCINONIDE) HALCINONIDE 1 mg in 1 g

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL DIMETHICONE 350 GLYCERYL MONOSTEARATE ISOPROPYL PALMITATE POLYSORBATE 60 PROPYLENE GLYCOL WATER TITANIUM DIOXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71428-011-30 1 TUBE in 1 CARTON contains a TUBE 1 30 g in 1 TUBE This package is contained within the CARTON (71428-011-30) 2 NDC:71428-011-60 1 TUBE in 1 CARTON contains a TUBE 2 60 g in 1 TUBE This package is contained within the CARTON (71428-011-60)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214723 12/08/2021

Labeler — Glasshouse Pharmaceuticals Limited Canada (203493598)

Revised: 04/2022 Glasshouse Pharmaceuticals Limited Canada