Hydrocortisone (Page 2 of 2)

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Hydrocortisone Cream USP, 2.5% is available as follows:
20 g tube (NDC 45802-004 -02)

1 oz. (28 g) tube (NDC 45802-004 -03)

Hydrocortisone Ointment USP, 2.5% is available as follows:
20 g tube (NDC 45802-014 -02)

1 lb. jar (NDC 45802-014 -05)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Keep out of the reach of children.

Manufactured By Perrigo plc, Bronx, NY 10457

Distributed By Padagis
Allegan, MI 49010

www.padagis.com

Rev 01-22

:1F300 RC JX2

Principal Display Panel — Hydrocortisone Cream USP, 2.5% — 28 g

NDC 45802-004-03

Rx Only

Hydrocortisone Cream USP, 2.5%

NET WT 28 g

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

Principal Display Panel — Hydrocortisone Ointment USP, 2.5% — 20 g

NDC 45802-014-02

Rx Only

Hydrocortisone Ointment USP, 2.5%

NET WT 20 g

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

HYDROCORTISONE hydrocortisone cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-004 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 25 mg in 1 g

Inactive Ingredients Ingredient Name Strength WATER STEARYL ALCOHOL PROPYLENE GLYCOL CETYL ALCOHOL SODIUM LAURYL SULFATE METHYLPARABEN PROPYLPARABEN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:45802-004-02 1 TUBE in 1 CARTON contains a TUBE 1 20 g in 1 TUBE This package is contained within the CARTON (45802-004-02) 2 NDC:45802-004-03 1 TUBE in 1 CARTON contains a TUBE 2 28 g in 1 TUBE This package is contained within the CARTON (45802-004-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA085025 03/31/2006

HYDROCORTISONE hydrocortisone ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-014 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 25 mg in 1 g

Inactive Ingredients Ingredient Name Strength PETROLATUM LIGHT MINERAL OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:45802-014-02 1 TUBE in 1 CARTON contains a TUBE 1 20 g in 1 TUBE This package is contained within the CARTON (45802-014-02) 2 NDC:45802-014-05 454 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA085027 06/13/2006

Labeler — Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 01/2022 Padagis Israel Pharmaceuticals Ltd