EPIDUO (Page 3 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

EPIDUO (adapalene and benzoyl peroxide) gel 0.1% / 2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows:

45 gram tube NDC 0299-5908-45
45 gram pump NDC 0299-5908-25

Storage and handling

— Store at 25ºC; excursions permitted to 15º — 30ºC (59º — 86ºF).

— Protect from light.

— Keep out of reach of children.

— Keep away from heat.

— Keep tube tightly closed.

17 PATIENT COUNSELING INFORMATION

[See FDA approved Patient Labeling (Patient Information)]

Information for Patients

– Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply EPIDUO gel as a thin layer, avoiding the eyes, lips and mucous membranes.

– Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation.

– EPIDUO gel may cause irritation such as erythema, scaling, dryness, stinging or burning.

– Advise patients to minimize exposure to sunlight, including sunlamps.

– Recommend the use of sunscreen products and protective apparel, (e.g., hat) when exposure cannot be avoided.

– EPIDUO gel may bleach hair and colored fabric.

Patient Information
EPIDUO® (Ep-E-Do-Oh)
(adapalene and benzoyl peroxide)
gel 0.1%/2.5%

Important: For use on the skin only (topical). Do not use EPIDUO gel in or on your mouth, eyes, or vagina.

Read this Patient Information leaflet about EPIDUO gel before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about EPIDUO gel, talk with your doctor or pharmacist.

What is EPIDUO gel?
EPIDUO gel is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age and older.

Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

It is not known if EPIDUO gel is safe and effective in children younger than 9 years old.

What should I tell my doctor before using EPIDUO gel?
Before you use EPIDUO gel, tell your doctor if you:

  • have other skin problems, including cuts or sunburn
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if EPIDUO gel can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if EPIDUO gel passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use EPIDUO gel.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Especially tell your doctor if you use any other medicine for acne. Using EPIDUO gel with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use EPIDUO gel?

  • Use EPIDUO gel exactly as your doctor tells you to use it. EPIDUO gel is for skin use only. Do not use EPIDUO gel in or on your mouth, eyes, or vagina.
  • Apply EPIDUO gel 1 time a day.
  • Do not use more EPIDUO gel than you need to cover the treatment area. Using too much EPIDUO gel or using it more than 1 time a day may increase your chance of skin irritation.

Applying EPIDUO gel:

  • Wash the area where the gel will be applied with a mild cleanser and pat dry.
  • EPIDUO gel comes in a tube and a pump. If you have been prescribed the:
    • Tube: Squeeze a small amount (about the size of a pea) of EPIDUO gel onto your fingertips and spread a thin layer over the affected area.
    • Pump: Depress the pump to dispense a small amount (about the size of a pea) of EPIDUO gel and spread a thin layer over the affected area.

What should I avoid while using EPIDUO gel?

  • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. EPIDUO gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should wear sunscreen and wear a hat and clothes that cover the areas treated with EPIDUO gel if you have to be in sunlight.
  • You should avoid weather extremes such as wind and cold as this may cause irritation to your skin.
  • You should avoid applying EPIDUO gel to cuts, abrasions and sunburned skin.
  • You should avoid skin products that may dry or irritate your skin such as harsh soaps, astringents, cosmetics that have strong skin- drying effects and products containing high levels of alcohol.
  • You should avoid the use of “waxing” as a hair removal method on skin treated with EPIDUO gel.
  • EPIDUO gel may bleach your clothes or hair. Allow EPIDUO gel to dry completely before dressing to prevent bleaching of your clothes.

What are the possible side effects of EPIDUO gel?

EPIDUO gel may cause serious side effects including:

  • Local skin reactions. Local skin reactions are most likely to happen during the first 4 weeks of treatment and usually lessen with continued use of EPIDUO gel. Signs and symptoms of local skin reaction include:
    • Redness
    • Dryness
    • Swelling
    • Scaling
    • Stinging or burning

Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse, you may have to stop using EPIDUO gel.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of EPIDUO gel. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to GALDERMA LABORATORIES, L.P. at 1-866-735-4137

How should I store EPIDUO gel?

  • Store EPIDUO gel at room temperature, 68° — 77° F (20° — 25° C).
  • Keep EPIDUO gel inside container and out of light and away from heat.

Keep EPIDUO gel and all medicines out of the reach of children.

General information about EPIDUO gel

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use EPIDUO gel for a condition for which it was not prescribed. Do not give EPIDUO gel to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about EPIDUO gel. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about EPIDUO gel that is written for health professionals.

What are the ingredients in EPIDUO gel?
Active ingredient: adapalene and benzoyl peroxide
Inactive ingredients: acrylamide/sodium acryloydimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan oleate

Revised: January 2013

Marketed by:
GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA
Manufactured by:
G Production Inc., Baie d’Urfé, QC, H9X 3S4 Canada
Made in Canada.
GALDERMA is a registered trademark.P51740-2

PACKAGE LABEL 45 g PUMP

45-gram-pump-carton
(click image for full-size original)

Rx Only NDC 0299-5908-25
Epiduo®
(adapalene and benzoyl peroxide) Gel 0.1% / 2.5%
PUMP
FOR TOPICAL USE ONLY
NET WT. 45g
GALDERMA

For topical use only. Not for ophthalmic, oral or intravaginal use.
Usual dosage: Apply a thin film once a day to affected areas.
See package insert for complete prescribing information.
Each gram contains: Active: adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous gel consisting of: Inactive: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.
Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° and 86°F (15° and 30°C).
See carton closure for lot number and expiration date.

Marketed by:
GALDERMA LABORATORIES, L.P.
14501 North Freeway, Fort Worth, TX 76177 USA
Made in Canada.
All trademarks are the property of their respective owners.
www.epiduo.com
P51741-3

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