HALOG (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 HALOG SOLUTION (Halcinonide Topical Solution, USP) 0.1% to the affected area two to three times daily.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply the solution to 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 HALOG SOLUTION 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 solution 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

HALOG^® SOLUTION (Halcinonide Topical Solution, USP) 0.1% is supplied in plastic squeeze bottles containing, 60 mL (NDC 10631-095-20), and 120 mL (NDC 10631-095-10) of solution.

Storage

Store at room temperature; avoid freezing and temperatures above 104° F.

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Revised July 2019

PPK-8860-0

29

LABEL PRINCIPAL DISPLAY PANEL-60mL

LABEL PRINCIPAL DISPLAY PANEL-120mL

LABEL PRINCIPAL DISPLAY PANEL-Physician Sample

HALOG halcinonide topical solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-095 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM POLYETHYLENE GLYCOL 300 WATER BUTYLATED HYDROXYTOLUENE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10631-095-20 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 60 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (10631-095-20) 2 NDC:10631-095-10 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 2 120 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (10631-095-10) 3 NDC:10631-095-98 4 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC (10631-095-06) 3 NDC:10631-095-06 5 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (10631-095-98)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017823 03/18/2020

Labeler — Sun Pharmaceutical Industries, Inc. (146974886)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE (10631-095)

Revised: 05/2021 Sun Pharmaceutical Industries, Inc.