ENSTILAR (Page 5 of 5)

INSTRUCTIONS FOR USE ENSTILAR® [EN-still-ar] (calcipotriene and betamethasone dipropionate) Foam

This Instructions for Use contains information on how to apply Enstilar Foam.

Important Information You Need to Know Before Applying Enstilar Foam: Enstilar Foam is for use on skin only (topical). Do not get Enstilar Foam near or in your mouth, eyes or vagina. If you accidentally get Enstilar Foam on the face, in the mouth or in the eyes, wash the area with water right away. Do not swallow Enstilar Foam.

Applying Enstilar Foam:

Follow your healthcare provider’s instructions on how much Enstilar Foam to use and where to use it.

Step 1
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Wash your hands before applying Enstilar Foam. Step 1: Remove the cap from the can. Shake the can before use.

Step 2
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Step 2: Hold the can at least 1.5 inches from the affected area.

Step 3
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Step 3: The foam can be sprayed holding the can in any position except sideways (horizontally).To spray, push down on the nozzle. Note: Enstilar Foam will slowly become smaller in size after spraying.

Step 4
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Step 4: Gently rub in Enstilar Foam into your affected skin area. Repeat the steps above to apply Enstilar Foam to other affected areas as instructed by your healthcare provider.
Step 5: After applying Enstilar Foam, put the cap back on the can.
Step 6: Wash your hands after using Enstilar Foam unless you are using the medicine to treat your hands.

Storing Enstilar Foam

  • Store Enstilar Foam at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not expose Enstilar Foam to heat or store at temperatures above 120°F (49°C).
  • Do not puncture or burn the Enstilar Foam can.
  • Do not freeze Enstilar Foam.

Disposing of Enstilar Foam

  • Enstilar Foam has an expiration date (exp.) marked on the can. Do not use after this date.
  • Throw away (dispose of) unused Enstilar Foam 6 months after the can has been opened.

Keep Enstilar Foam and all medicines out of the reach of children.

Manufactured by:
LEO Laboratories Ltd.
285 Cashel Road
Dublin 12, Ireland

Distributed by:
LEO Pharma Inc.
Madison, NJ 07940, USA

Enstilar® is a registered trademark of LEO Pharma A/S.
© 2022, LEO Pharma Inc. All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 4/2022

PRINCIPAL DISPLAY PANEL — 60 gram Can Carton

NDC 50222-302-60

Rx only

Enstilar®
(calcipotriene and
betamethasone
dipropionate)
Foam, 0.005%/0.064%

Shake before Use

For Topical Use Only

Not for oral, ophthalmic,
or intravaginal use

Net Wt. 60 gram

LEO®

PRINCIPAL DISPLAY PANEL -- 60 gram Can Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 120 gram Can Carton

NDC 50222-302-66
Rx only

Enstilar®
(calcipotriene and betamethasone
dipropionate)
Foam, 0.005%/0.064%

Shake before Use

For Topical Use Only

Not for oral, ophthalmic, or intravaginal use

Net Wt. 120 gram (2 cans of 60 gram)

LEO®

PRINCIPAL DISPLAY PANEL -- 120 gram Can Carton
(click image for full-size original)
ENSTILAR calcipotriene and betamethasone dipropionate aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50222-302
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE MONOHYDRATE (CALCIPOTRIENE) CALCIPOTRIENE 50 ug in 1 g
BETAMETHASONE DIPROPIONATE (BETAMETHASONE) BETAMETHASONE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
BUTANE
DIMETHYL ETHER
POLYPROPYLENE GLYCOL 11 STEARYL ETHER
MINERAL OIL
.ALPHA.-TOCOPHEROL, DL-
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50222-302-60 1 CAN in 1 CARTON contains a CAN
1 60 g in 1 CAN This package is contained within the CARTON (50222-302-60)
2 NDC:50222-302-91 1 CAN in 1 CARTON contains a CAN
2 60 g in 1 CAN This package is contained within the CARTON (50222-302-91)
3 NDC:50222-302-66 2 CAN in 1 CARTON contains a CAN
3 60 g in 1 CAN This package is contained within the CARTON (50222-302-66)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207589 10/16/2015
Labeler — LEO Pharma Inc. (832692615)
Establishment
Name Address ID/FEI Operations
LEO Laboratories Ltd. 219532322 ANALYSIS (50222-302), MANUFACTURE (50222-302), PACK (50222-302), LABEL (50222-302)

Revised: 10/2021 LEO Pharma Inc.

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