HALCINONIDE (Page 2 of 2)

Geriatric Use

Of approximately 3000 patients included in clinical studies of 0.1% halcinonide cream, 14% were 60 years or older, while 4% were 70 years or older. No overall differences in safety were observed between these patients and younger patients. Efficacy data have not been evaluated for differences between elderly and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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, USP, 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 smooth, soft homogeneous white to off-white cream, essentially free of foreign matter and is supplied as:

NOC 57664-698-36 Tube containing 60 g

Storage

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

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by:

DPT Laboratories Inc.

San Antonio, TX 78215

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

141012

Issued September 2019

Halcinonide 60g Carton Label

PDP-01
(click image for full-size original)
HALCINONIDE
halcinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-698
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
GLYCERYL MONOSTEARATE
CETYL ALCOHOL
ISOPROPYL PALMITATE
DIMETHICONE 350
POLYSORBATE 60
TITANIUM DIOXIDE
PROPYLENE GLYCOL
WATER
Product Characteristics
Color white (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-698-36 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (57664-698-36)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA017556 05/22/2021
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd 832224526 MANUFACTURE (57664-698), PACK (57664-698)

Revised: 05/2021 Sun Pharmaceutical Industries, Inc.

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