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CombiPatch (estradiol/norethindrone acetate transdermal system): Uses, Side Effects and Dosage

Status:
Prescription (Rx) Boxed warning Facts
Strength:
0.05 mg/day, 0.14 mg/day, 0.05 mg/day, 0.25 mg/day
Other brand names:
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - CombiPatch (estradiol/norethindrone acetate transdermal system)

Instructions for Use

CombiPatch

(käm-bē `pach)

(estradiol/norethindrone acetate transdermal system)

Step 1. Pick the days you will change your CombiPatch.

  • You will need to change your patch every 3 to 4 days (twice weekly).

Step 2. Remove CombiPatch from the pouch.

  • Tear open the protective pouch at the slit (do not use scissors) and remove the patch. See Figure A.
  • The pouch should not be opened until you are ready to put the patch on.

Step 3. Remove the adhesive liner.

  • Peel off one side of the protective liner. See Figure B.
  • Do not touch the sticky part of the patch with your fingers. See Figure B.

Step 4. Placing the CombiPatch on your skin.

  • Put the sticky side of the patch on the lower abdomen (below the panty line). See Figure C.
  • Peel off the second side of the protective liner. See Figure C.
  • Press the patch firmly in place with your hand for about 10 seconds. See Figure D.

Note:

  • Avoid the waistline, since clothing and belts may cause the CombiPatch to be rubbed off.
  • Do not apply the CombiPatch to or near your breasts.
  • Only apply the CombiPatch to skin that is clean, dry, and free of any powder, oil, or lotion.
  • You should not apply the CombiPatch 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 CombiPatch firmly onto your skin.

  • Rub the edges of the CombiPatch with your fingers to make sure that it will stick to your skin. See Figure E.

Note:

  • Bathing, swimming, or showering will not affect the CombiPatch.
  • Once in place, the patch should not be exposed to the sun for prolonged periods of time.
  • If your CombiPatch falls off reapply it. If you cannot reapply the CombiPatch, apply a new CombiPatch to another area (See Figures C , D and E) and continue to follow your original placement schedule.
  • If you stop using your CombiPatch or forget to apply a new CombiPatch as scheduled you may have spotting, or bleeding, and your symptoms may come back.

Step 6. Throwing away your used CombiPatch.

  • When it is time to change your CombiPatch, remove the old CombiPatch before you apply a new one.
  • 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.

Manufactured by:

Noven Pharmaceuticals Inc.

Miami, FL 33186

Distributed by:

Noven Therapeutics, LLC

Miami, FL 33186

For more information call 1-800-455-8070 or visit www.combipatch.com.

© 2024 Noven Pharmaceuticals, Inc.

102538-5

02/2024

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 020870 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for CombiPatch (estradiol/norethindrone acetate transdermal system)

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Estrogen, Progestin
Active ingredients Estradiol 0.05 mg/day, Norethindrone acetate
Dosage form Patch, extended release
Route Transdermal
Marketing status listed in the FDA NDC Directory
Company (applicant) NOVEN PHARMS INC
FDA approval NDA 020870New Drug Application (NDA) Approved August 7, 1998
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.05 mg/day, 0.14 mg/day – 3.5 d in 1 patch / 1 in 1 pouch / 8 in 1 carton NDC 68968-0514-8
0.05 mg/day, 0.25 mg/day – 3.5 d in 1 patch / 1 in 1 pouch / 8 in 1 carton NDC 68968-0525-8

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.