Amcinonide (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 three times daily depending on the severity of the condition.

Occlusive dressings may be a valuable therapeutic adjunct 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

Amcinonide Cream USP, 0.1% (1 mg/g) is supplied as follows:

NDC 0168-0278-15 15 gram tubes
NDC 0168-0278-30 30 gram tubes
NDC 0168-0278-60 60 gram tubes

Store at 20°C to 25°C (68°F to 77°F),excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. DO NOT FREEZE.

E. FOUGERA & CO.
A division of
Fougera
PHARMACEUTICALS INC.
Melville, New York 11747

46260501A
R03/2020
#53

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 15 GRAM TUBE

NDC 0168-0278-15

Fougera ®

AMCINONIDE
CREAM USP, 0.1%

Rx Only

NOT FOR OPHTHALMIC USE.
FOR DERMATOLOGIC USE ONLY.

NET WT 15 grams

15gramtube
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 15 GRAM CARTON

NDC 0168-0278-15

Rx Only

Fougera ®

AMCINONIDE
CREAM USP, 0.1%

NOT FOR OPHTHALMIC USE.
FOR DERMATOLOGIC USE ONLY.

WARNING: Keep out of
reach of children.

NET WT 15 grams

15gramcarton
(click image for full-size original)
AMCINONIDE
amcinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0278
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amcinonide (Amcinonide) Amcinonide 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
water
sorbitol
LACTIC ACID, UNSPECIFIED FORM
glycerin
isopropyl palmitate
benzyl alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0278-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0168-0278-15)
2 NDC:0168-0278-30 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (0168-0278-30)
3 NDC:0168-0278-60 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (0168-0278-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076065 05/15/2003
Labeler — Fougera Pharmaceuticals Inc. (043838424)

Revised: 06/2022 Fougera Pharmaceuticals Inc.

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