Betamethasone Dipropionate (Page 2 of 2)

OVERDOSAGE:

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

DOSAGE AND ADMINISTRATION:

Apply a few drops of Betamethasone Dipropionate Lotion to the affected skin areas and massage lightly until it disappears. Apply twice daily, in the morning and at night.

If an infection develops, appropriate antimicrobial therapy should be instituted.

Betamethasone Dipropionate products should not be used with occlusive dressings.

HOW SUPPLIED:

Betamethasone Dipropionate Lotion, USP 0.05% is supplied as follows:
60 mL bottles (NDC 0713-0728-53)
Shake well before using.
Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing.

Manufactured by:

Cosette Pharmaceuticals, Inc.

South Plainfield, NJ 07080

Rev. 11/2019

8-0728ALM3

PRINCIPAL DISPLAY PANEL

NDC 0713-0728-53

Betamethasone Dipropionate Lotion, USP 0.05%

60 mL

Rx only

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

Cosette Pharmaceuticals, Inc.

BETAMETHASONE DIPROPIONATE betamethasone dipropionate lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0728 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETAMETHASONE DIPROPIONATE (BETAMETHASONE) BETAMETHASONE 0.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL WATER CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0713-0728-53 1 BOTTLE in 1 CARTON contains a BOTTLE 1 60 mL in 1 BOTTLE This package is contained within the CARTON (0713-0728-53)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA071467 08/10/1987 01/31/2023

Labeler — Cosette Pharmaceuticals, Inc. (116918230)

Registrant — Cosette Pharmaceuticals, Inc. (116918230)

Establishment
Name	Address	ID/FEI	Operations
Cosette Pharmaceuticals, Inc.		116918230	analysis (0713-0728), label (0713-0728), manufacture (0713-0728), pack (0713-0728)

Revised: 04/2022 Cosette Pharmaceuticals, Inc.