DIFFERIN (Page 3 of 4)

16 HOW SUPPLIED/ STORAGE AND HANDLING

DIFFERIN Gel, 0.3% is supplied in the following size.

15 g tube — NDC 0299-5918-15

45 g tube – NDC 0299-5918-45

45 g pump — NDC 0299-5918-25

Storage : Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C). Protect from freezing. Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Information for Patients
Patients using DIFFERIN Gel should receive the following information and instructions:

  1. Apply a thin film of DIFFERIN Gel to the entire face and any other affected areas of the skin once daily in the evening. Apply a thin film of DIFFERIN Gel to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.
  2. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes
  3. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.
  4. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin.
  5. Wax depilation should not be performed on treated skin due to the potential for skin erosions.
  6. Minimize exposure to sunlight including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.
  7. Contact the doctor if skin rash, pruritus, hives, chest pain, edema, and shortness of breath occurs, as these may be signs of allergy or hypersensitivity.
  8. This product is for external use only.
  9. Lactation: Use DIFFERIN Gel on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid application of DIFFERIN Gel to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. [See Use in Specific Populations, Lactation (8.2)]

Patient Information

DIFFERIN® [Dif-er-in]
(adapalene)
Gel

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

Read this Patient Information that comes with DIFFERIN 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 DIFFERIN Gel talk with your doctor or pharmacist.

What is DIFFERIN Gel?
DIFFERIN Gel is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 12 years of age and older.
Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.
It is not known if DIFFERIN Gel is safe and effective in children younger than 12 years of age or in people 65 years of age and older.

Who should not use DIFFERIN Gel?
Do not use DIFFERIN Gel if you:

  • are allergic to adapalene or any of the ingredients in DIFFERIN Gel. See the end of this Patient Information for a complete list of ingredients in DIFFERIN Gel.

What should I tell my doctor before using DIFFERIN Gel?
Before you use DIFFERIN 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 DIFFERIN 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 DIFFERIN 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 DIFFERIN 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 DIFFERIN 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 DIFFERIN Gel?

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

Applying DIFFERIN Gel:

  • Wash the area where DIFFERIN Gel will be applied with a soap that does not contain a medicine and pat dry.
  • DIFFERIN Gel comes in a tube and a pump. If you have been prescribed the:
    • Tube: Squeeze a small amount onto your fingertips and spread a thin layer over the entire face and any other affected areas.
    • Pump: Depress the pump to dispense a small amount of DIFFERIN Gel and spread a thin layer over the entire face and any other affected area.

What should I avoid while using DIFFERIN Gel?

  • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. DIFFERIN Gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should wear sunscreen and wear hat and clothes that cover the areas treated with DIFFERIN 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 DIFFERIN 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 DIFFERIN Gel.

What are the possible side effects of DIFFERIN Gel?
DIFFERIN 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 DIFFERIN Gel. Signs and symptoms of local skin reaction include:
    • Redness
    • Dryness
    • Scaling
    • Stinging or burning
  • Allergic reactions. DIFFERIN Gel may cause an allergic reaction that may require medical treatment. Stop using DIFFERIN Gel and tell your doctor right away if you have any of these symptoms of an allergic reaction:
    • skin rash, itching or hives
    • trouble breathing or chest pain
    • swelling of your face, eyes, lips, tongue or throat

You may use a moisturizer for relief of dry skin or irritation, however you should avoid products that contain alpha hydroxy or glycolic acid.

The most common side effects of DIFFERIN Gel are:

  • skin pain
  • skin peeling
  • sunburn

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 DIFFERIN 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 1-866-7354137.

How should I store DIFFERIN Gel?

  • Store DIFFERIN Gel, 0.3% at room temperature between 68° F to 77° F (20° C to 25° C).
  • Do not freeze DIFFERIN Gel.

Keep DIFFERIN Gel and all medicines out of the reach of children.

General information about DIFFERIN Gel
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use DIFFERIN Gel for a condition for which it was not prescribed. Do not give DIFFERIN 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 DIFFERIN Gel. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about DIFFERIN Gel that is written for health professionals.

What are the ingredients in DIFFERIN Gel?
Active ingredient: adapalene
Inactive ingredients: carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid for pH adjustment.

This Patient Information has been approved by the U.S. Food and Drug Administration.
Marketed by: GALDERMA LABORATORIES, L.P., Dallas, Texas 75201 USA
Manufactured by:
G Production Inc., Baie d’Urfé, QC, H9X 3S4 Canada
Made in Canada.
All trademarks are the property of their respective owners.
P52321-X Issued: 08/2022

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