Veregen (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Veregen is a brown ointment and is supplied in an aluminum tube containing 30 grams (NDC 62559-385-30) of ointment per tube.

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

KEEP OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

Patients using Veregen should receive the following information and instructions:

This medication is only to be used as directed by a physician. It is for external use only. Eye contact should be avoided as well as application into the vagina or anus.
It is not necessary to wash off Veregen prior to the next application. When the treatment area is washed or a bath is taken, the ointment should be applied afterwards.
It is common for patients to experience local skin reactions such as erythema, erosion, edema, itching, and burning at the site of application. Severe skin reactions can occur and should be promptly reported to the healthcare provider. Should severe local skin reaction occur, the ointment should be removed by washing the treatment area with mild soap and water, and further doses withheld.
Sexual (genital, anal or oral) contact should be avoided while the ointment is on the skin, or the ointment should be washed off prior to these activities. Veregen may weaken condoms and vaginal diaphragms. Therefore, the use in combination with Veregen is not recommended.
Female patients using tampons should insert the tampon before applying the ointment. If the tampon is changed while the ointment is on the skin, accidental application of the ointment into the vagina must be avoided.
Veregen may stain clothing and bedding.
Veregen is not a cure and new warts might develop during or after a course of therapy. If new warts develop during the 16-week treatment period, these should also be treated with Veregen.
The effect of Veregen on the transmission of genital/perianal warts is unknown.
Patients should be advised to avoid exposure of the genital and perianal area to sun/UV light as Veregen has not been tested under these circumstances.
The treatment area should not be bandaged or otherwise covered or wrapped as to be occlusive.
Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.

Patient Package Insert

PATIENT INFORMATION

V eregen®
(sinecatechins)
Ointment, 15%

Read this leaflet carefully before you start using Veregen Ointment and each time you refill your prescription. There may be new information. This information does not take the place of your doctor’s advice. If you have any questions about Veregen Ointment or your condition ask your doctor or pharmacist. Only your doctor can prescribe Veregen and determine if it is right for you.

What is Veregen Ointment?

Veregen Ointment is a medicine for skin use only (topical) for the treatment of warts on the outside of the genitals and around the outside of the anus. It is not a treatment for warts in the vagina, cervix, or inside the anus. Your doctor may recommend examination and screening tests (such as a Pap smear) to evaluate these areas.

Who should not use Veregen Ointment?

Do not use Veregen Ointment if you are allergic to an ingredient in Veregen Ointment. The list of ingredients is at the end of this leaflet.

What should I tell my doctor before using Veregen Ointment?

Tell your doctor about all your health conditions and all the medicines you take including prescription, over-the-counter medicine, vitamins, supplements, and herbals. Be sure to tell your doctor if you are:

pregnant or planning to become pregnant , as it is not known if Veregen Ointment can harm your unborn baby. Your doctor will determine whether the benefit outweighs the risk.
breastfeeding , as it is not known if Veregen Ointment can pass into your milk and if it can harm your baby.
using any other type of skin product or have open wounds on the area to be treated. Veregen Ointment should not be used until your skin has healed from other treatments applied to the same area.
immunocompromised. This means that your immune system cannot fight infections as well as it should.

How should I use Veregen Ointment?

Use Veregen Ointment only on the area affected exactly as prescribed by your doctor.
Wash your hands before and after application of Veregen Ointment. A small amount of the ointment should be applied to all warts using your finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts as directed by your doctor.
Apply Veregen Ointment three times per day — in the morning, at noontime and in the evening. Do not wash off the ointment from the treated area before the next application. When you wash the treatment area or bathe, apply the ointment afterwards.
Treatment with Veregen Ointment should be continued until complete clearance of all warts, however no longer than 16 weeks. If your warts do not go away, or if they come back after treatment call your doctor.
Veregen Ointment is not a cure for warts on your genitals or around your anus with certainty. New warts may develop during or after treatment, and may need treatment.

What should I avoid while using Veregen Ointment?

Do not apply Veregen Ointment on open wounds or into the vagina or into the anus.
Genital warts are a sexually transmitted disease, and you may infect your partner.
Avoid sexual contact (genital, anal or oral) when Veregen Ointment is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms. Talk to your doctor about safe sex practices.
Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).
Women using tampons: insert the tampon before applying the ointment. If you need to change your tampon while the ointment is on your skin, avoid getting the ointment into the vagina.
Uncircumcised men treating warts under the foreskin should retract the foreskin and clean the area daily.
Do not expose the genital area treated with Veregen Ointment to sunlight, sunlamps or tanning beds.
Do not cover the treated area. Loose-fitting undergarments can be worn after applying Veregen Ointment.
Veregen Ointment may stain your light colored clothes and bedding.

What are the possible side effects of Veregen Ointment?

The most common side effects with Veregen Ointment are local skin and application site reactions including:

redness
swelling
sores or blisters
burning
itching
pain

Many patients experience itching, reddening or swelling on or around the application site during the course of treatment. Some of these side effects could be a sign of an allergic reaction. If you experience open sores or other severe reactions at the locations you applied Veregen Ointment, stop treatment and call your doctor right away.

You may experience other side effects of Veregen Ointment which are not mentioned here. Ask your doctor or pharmacist for more information.

Patients should be aware that new warts may develop during treatment as Veregen Ointment is not a cure.

How should I store Veregen Ointment?

Store Veregen Ointment refrigerated or up to 77°F (25°C).
Do not freeze.
Make sure the cap on the tube is tightly closed.
Safely throw away Veregen Ointment tubes that are out of date or are empty.

Keep Veregen Ointment and all medicines out of the reach of children.

General advice about prescription medicines

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Veregen Ointment for a condition for which it was not prescribed. Do not give Veregen Ointment to other people, even if they have the same symptoms you have. It may harm them.

Do not use Veregen Ointment after the expiration date on the tube.

This leaflet summarizes the most important information about Veregen Ointment. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Veregen Ointment that is written for the doctor.

For more information, go to www.anipharmaceuticals.com or call 1-800-308-6755.

What are the ingredients in Veregen Ointment?

Active ingredient:

A defined green tea extract named sinecatechins.

Inactive ingredients:

Isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.

Manufactured by:
C.P.M. ContractPharma GmbH.
Frühlingstrasse 7 D-83620
Feldkirchen-Westerham, Germany

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
ANI-LOGO

U.S. Patent Nos. 5795911 and 5968973

0-20720-00 Rev 01/22

This Patient Information has been approved by the U.S. Food and Drug Administration.

VEREGEN®
(sinecatechins) Ointment
15 %
For Topical Use Only
30g

30g-carton
(click image for full-size original)
30g-carton
VEREGEN
sinecatechins ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-385
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SINECATECHINS (SINECATECHINS) SINECATECHINS 150 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL MYRISTATE
PETROLATUM
WHITE WAX
PROPYLENE GLYCOL MONOPALMITOSTEARATE
OLEYL ALCOHOL
Product Characteristics
Color BROWN Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-385-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (62559-385-30)
2 NDC:62559-385-26 6 CARTON in 1 CARTON contains a CARTON (62559-385-02)
2 NDC:62559-385-02 1 TUBE in 1 CARTON This package is contained within the CARTON (62559-385-26) and contains a TUBE
2 2 g in 1 TUBE This package is contained within a CARTON (62559-385-02) and a CARTON (62559-385-26)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021902 11/10/2022
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 11/2022 ANI Pharmaceuticals, Inc.

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