Differin (Page 3 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

DIFFERIN (adapalene) Lotion, 0.1%, is a white to off-white liquid packaged in a 2 oz (59 mL) bottle which is equipped with a lotion dispensing pump.

DIFFERIN Lotion is supplied as follows:

2 oz bottle pump NDC 0299-5912-02

Storage and handling

  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [see USP Controlled Room Temperature]
  • Do not freeze.
  • Do not refrigerate.
  • Protect from light.
  • Keep out of reach of children.
  • Keep away from heat.
  • Keep bottle tightly closed.

17 PATIENT COUNSELING INFORMATION

Patients using DIFFERIN Lotion should receive the following information and instructions:

  • Wash affected areas gently with a mild soapless cleanser.
  • Dispense a nickel size amount of DIFFERIN Lotion (3-4 actuations of the pump) and apply a thin film to the entire face and other affected areas of the skin once daily.
  • Avoid application to the areas of skin around eyes, lips and mucous membranes.
  • Do not apply to cuts, abrasions, eczematous, or sunburned skin.
  • Wax depilation should not be performed on treated skin due to the potential for skin erosions.
  • DIFFERIN Lotion may cause irritation such as erythema, scaling, dryness, stinging or burning. Minimize exposure to sunlight including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.
  • Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.
  • This product is for external use only.
  • 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.
  • Lactation: Use DIFFERIN Lotion on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply DIFFERIN Lotion to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. [See Use in Specific Populations, Lactation (8.2) ]

Marketed by:
GALDERMA LABORATORIES, L.P., Dallas, Texas 75201 USA
Made in Canada.
All trademarks are property of their respective owners.
P51503-X

PATIENT MEDICATION INFORMATION SECTION

Patient Information
DIFFERIN® (Dif-er-in)
(adapalene)
Lotion

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

What is DIFFERIN Lotion?
DIFFERIN Lotion is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.
It is not known if DIFFERIN Lotion is safe and effective in children under 12 years of age.

Do not use DIFFERIN Lotion if you are allergic to adapalene or any of the ingredients in DIFFERIN Lotion. See the end of this Patient Information leaflet for a complete list of ingredients in DIFFERIN Lotion.

Before using DIFFERIN Lotion, tell your healthcare provider about all your medical conditions, including if you:

  • have other skin problems, including cuts, abrasions, sunburn, or skin that is dry, itchy or red
  • are pregnant or plan to become pregnant. It is not known if DIFFERIN Lotion can harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if DIFFERIN Lotion passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use DIFFERIN Lotion. If you use DIFFERIN Lotion while breastfeeding, use DIFFERIN Lotion on the smallest area of the skin and for the shortest time needed. Do not apply DIFFERIN Lotion to areas that may increase the risk of getting DIFFERIN Lotion in your child’s mouth or eyes.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

How should I use DIFFERIN Lotion?

  • Use DIFFERIN Lotion exactly as your healthcare provider tells you to use it.
  • Apply DIFFERIN Lotion 1 time a day.

Applying DIFFERIN Lotion:

  • Wash the area where DIFFERIN Lotion will be applied gently with a mild soapless cleanser and pat dry.
  • DIFFERIN Lotion comes in a pump. Dispense a nickel size amount of DIFFERIN Lotion (3 to 4 pumps) and apply a thin layer over the entire face and any other affected area of the skin. Do not apply DIFFERIN Lotion on areas of the skin around your eyes, lips, nose and mouth.
  • Wash your hands after applying DIFFERIN Lotion.

What should I avoid while using DIFFERIN Lotion?

  • Avoid spending time in sunlight, including sunlamps. DIFFERIN Lotion can make your skin sensitive to the sun and the light from sunlamps. Use sunscreen and wear a hat and clothes that cover the areas treated with DIFFERIN Lotion if you have to be in sunlight.
  • Cold weather and wind may irritate your skin treated with DIFFERIN Lotion.
  • Do not apply DIFFERIN Lotion to cuts, abrasions, sunburned skin, or skin that is dry, itchy or red.
  • Avoid skin products that may dry or irritate your skin such as harsh soaps or cleansers, soaps and cosmetics that make your skin dry, and products that contain high levels of alcohol, astringents, spices, or limes.
  • Avoid the use of “waxing” as a hair removal method on skin treated with DIFFERIN Lotion.

What are the possible side effects of DIFFERIN Lotion?
DIFFERIN Lotion may cause serious side effects, including:

  • Allergic reactions. DIFFERIN Lotion may cause serious allergic reactions that sometimes may require medical treatment. Stop using DIFFERIN Lotion and tell your healthcare provider or get medical help 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
  • Skin reactions at the treated site. DIFFERIN Lotion may cause skin reactions including redness, scaling, dryness, stinging, or burning. These skin reactions are most likely to happen during the first 2 weeks of treatment, and usually lessen with continued use of DIFFERIN Lotion. Your healthcare provider may tell you to use a moisturizer, decrease how often you use DIFFERIN Lotion, or stop treatment with DIFFERIN Lotion if you get any skin reactions. If you use a moisturizer, you should avoid moisturizers that contain alpha hydroxy or glycolic acid. Ask your healthcare provider or pharmacist if you are not sure.

The most common side effects of DIFFERIN Lotion include dry skin and skin irritation.
These are not all the possible side effects of DIFFERIN Lotion.

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 DIFFERIN Lotion?

  • Store DIFFERIN Lotion at room temperature between 68° F to 77° F (20° C to 25° C).
  • Do not freeze or refrigerate DIFFERIN Lotion.
  • Keep DIFFERIN Lotion out of light and away from heat.
  • Keep the DIFFERIN Lotion bottle tightly closed.

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

General information about the safe and effective use of DIFFERIN Lotion.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use DIFFERIN Lotion for a condition for which it was not prescribed. Do not give DIFFERIN Lotion to other people, even if they have the same symptoms you have. It may harm them. You can also ask your healthcare provider or pharmacist for information about DIFFERIN Lotion that is written for health professionals.

What are the ingredients in DIFFERIN Lotion?
Active ingredient: adapalene
Inactive ingredients: carbomer 941, disodium edetate, medium chain triglycerides, methylparaben, phenoxyethanol, poloxamer 124, polyoxyl-6-polyoxyl-32 palmitostearate, PPG-12/SMDI copolymer, propylene glycol, propylparaben, purified water, sodium hydroxide, and stearyl alcohol.

Marketed by: GALDERMA LABORATORIES, L.P., Dallas, Texas 75201 USA
Made in Canada.
GALDERMA is a registered trademark.
P51503-X
This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 04/2023

PACKAGE LABEL — 2 FL OZ CARTON

2-fl-oz-carton-image
(click image for full-size original)

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