Menostar (Page 10 of 10)

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Instructions for Use

MENOSTAR (Mĕn-ō-stär)

(estradiol transdermal system)

Read this Patient Information before you start using MENOSTAR and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

You will need the following supplies: See Figure A

Menostar Pouch
(click image for full-size original)

Figure A

Step 1: Pick the days you will change your MENOSTAR.

You will need to change your patch 1 time each week or every 7 days.

Step 2. Remove the MENOSTAR patch from the pouch.

Remove the patch from its protective pouch by tearing at the notch (do not use scissors). See Figure B
Do not remove your patch from the protective pouch until you are ready to apply it.
Removal of pouch
(click image for full-size original)

Figure B

Step 3. Remove the adhesive liner. See Figure C

You will see that MENOSTAR is an oval shaped clear patch that is attached to a thick, hard-plastic adhesive liner and covered by a clear, plastic film. See Figure C
To apply your patch you must first remove the protective, clear plastic film that is attached to the clear thicker plastic backing. See Figure D
There is a silver foil-sticker attached to the inside of the pouch. Do not remove the silver foil sticker from the pouch. See Figure E
Protective Backing
(click image for full-size original)

Figure C

Removal of backing
(click image for full-size original)

Figure D

Removing patch
(click image for full-size original)

Figure E

Step 4. Placing the patch on your skin.

Apply the sticky side of the patch to 1 of the areas of skin shown below. See Figure F and Figure G
Do not touch the sticky side of the patch with your fingers.
Front placement
(click image for full-size original)

Figure F

Back placement
(click image for full-size original)

Figure G

Note:

Avoid the waistline, since clothing and belts may cause the patch to be rubbed off.
Do not apply MENOSTAR to your breasts.
Only apply MENOSTAR to skin that is clean, dry, and free of any powder, oil, or lotion.
Do not apply the patch to injured, burned, or irritated skin, or areas with skin conditions (such as birth marks, tattoos, or that is very hairy).

Step 5. Press the patch firmly onto your skin.

Press the patch firmly in place with your fingers for at least 10 seconds.
Rub the edges of the patch to make sure that it will stick to your skin. (See Figure H)
Press in place
(click image for full-size original)

Figure H

Note:

Contact with water while you are swimming, using a sauna, bathing, or showering may cause the patch to fall off.
If your patch falls off reapply it. If you cannot reapply the patch, apply a new patch to another area (See Figure F and Figure G) and continue to follow your original application schedule.
If you stop using your MENOSTAR patch or forget to apply a new patch as scheduled, you may have spotting, or bleeding, or your symptoms may come back.

Step 6: Throwing away your used patch.

When it is time to change your patch, remove the old patch before you apply a new patch.
To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet.

This Patient Information and Instructions for Use have been approved by the U.S Food and Drug

Administration.

Revised: 9/2021

© 2013, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Menostar Individual Carton

NDC 50419-455-04 4 Transdermal Systems

Menostar

(estradiol transdermal system)
14 mcg/day

Contents: Each 3.25 cm2 system contains 1 mg estradiol
USP to provide 14 mcg of estradiol per day. The inactive
components are acrylate copolymer adhesive, fatty acidesters, and polyethylene backing.

For Transdermal Use Only.

Keep this and all drugs out of the reach of children.

Rx Only

Menostar Carton
(click image for full-size original)
MENOSTAR estradiol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-455
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 14 ug in 1 d
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-455-04 4 PATCH in 1 CARTON contains a PATCH
1 7 d in 1 PATCH This package is contained within the CARTON (50419-455-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020375 06/08/2004
Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)
Establishment
Name Address ID/FEI Operations
Kindeva Drug Delivery L.P. 128688199 MANUFACTURE (50419-455)

Revised: 12/2023 Bayer HealthCare Pharmaceuticals Inc.

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