DOSAGE & ADMINISTRATION SECTION.

DirectionsAdults and children 12 years of age and older:. use once dailyclean the skin gently and pat dry before applying the productcover the entire affected area with thin layer. For example, if your acne is on the face, apply the product to the entire face.applying more than directed will not provide faster or better results, but may worsen skin irritation.if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask doctor.Children under 12 years of age: do not use. use once daily. clean the skin gently and pat dry before applying the product. cover the entire affected area with thin layer. For example, if your acne is on the face, apply the product to the entire face.. applying more than directed will not provide faster or better results, but may worsen skin irritation.. if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask doctor.. Children under 12 years of age: do not use. Other information. store at 20C to 25C (68F to 77F)protect from freezingprotect from light and keep away from heat. store at 20C to 25C (68F to 77F). protect from freezing. protect from light and keep away from heat.

INACTIVE INGREDIENT SECTION.

Inactive Ingredients. acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.

INDICATIONS & USAGE SECTION.

Use. For the treatment of acne. For the treatment of acne.

INFORMATION FOR PATIENTS SECTION.

Patient Leaflet. DIFFERIN(R)EPIDUOACNE GELADAPALENE 0.1% and BENZOYL PEROXIDE 2.5% GELACNE TREATMENTFrequently Asked QuestionsWhat is Differin Epiduo Acne Gel and what is it used forDifferin Epiduo Acne Gel is topical medication used for the treatment of acne in people age 12 years and older. What should know before using Differin Epiduo Acne GelIf pregnant or breast-feeding, ask doctor before use. Some other retinoid drugs have been shown to cause birth defects. There is no specific evidence that Differin Epiduo Acne Gel causes birth defects in humans when used topically as directed. Do not use Differin Epiduo Acne Gel if you are allergic to adapalene or any of the ingredients in this product, if you have very sensitive skin or if are you sensitive to benzoyl peroxide. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.How often do apply Differin Epiduo Acne GelApply Differin Epiduo Acne Gel only one time day and try to apply the product at the same time each day.How do apply Differin Epiduo Acne GelGently clean the affected areas using mild (non-irritating) cleanser and pat dry.Apply Differin Epiduo Acne Gel as thin layer to the affected areas of the skin only one time day. For example, if you get acne on the face, clean, dry and apply the product to the entire face. Differin Epiduo Acne Gel is not spot treatment and should not be used to treat single pimple. Avoid contact with eyes, lips and mouth. If contact occurs, immediately flush the area with water. Do not apply to damaged skin (cuts, abrasions, eczema, or sunburn). Wash hands after use.How long will it take for Differin Epiduo Acne Gel to workIt may take up to months of daily use for results to appear. Do not use more than one time day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.What do do if need to be in the sunWhen possible, limit sun exposure, including light from tanning beds. When going outdoors, use sunscreen as labeled. Your skin may be more sensitive while using Differin Epiduo Acne Gel. If you use Differin Epiduo Acne Gel during the day, allow it to dry before applying sunscreen.DIFFERIN(R) EPIDUO ACNE GELADAPALENE 0.1% ANDBENZOYL PEROXIDE 2.5% GELACNE TREATMENTFrequently Asked Questions (Continued)Can use moisturizer if my skin is dryYes, use of moisturizer may help decrease dryness and other signs of irritation. Avoid 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.When is my skin most likely to become irritated And what do doIrritation (redness, itching, dryness, burning) is more likely to occur: In the first few weeks of use. if using abrasive skin cleansers, products with drying effects or more than one topical acne medication at time. You may want to delay starting Differin Epiduo Acne Gel until any irritation from using the other product(s) has gone away. in extreme weather such as wind and cold. Moisturizers may be used. Irritation usually lessens after weeks of continued use. What do do if my skin becomes severely irritatedIf irritation gets wors, stop use and ask doctor before using Differin Epiduo Acne Gel again.Can remove unwanted facial hair by waxing while using Differin Epiduo Acne GelDo not use wax to remove hair in areas where Differin Epiduo Gel has been applied because it may worsen skin irritation.What ingredients are used in Differin Epiduo Acne GelDifferin Epiduo Acne Gel contains:The active ingredients are adapalene 0.1% and benzoyl peroxide 2.5%. The other ingredients are: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.How should store this Differin Epiduo Acne GelDifferin Epiduo Acne Gel should be stored at 20C to 25C (68 77F). Protect from freezing. Protect from light and keep away from heat. Do not use Differin Epiduo Acne Gel after the expiry date marked on the packaging.Other Questions Where can get informationPhone: 1-866-735-4137See outer carton for complete warnings and information. PXXXXX-X. Differin Epiduo Acne Gel is topical medication used for the treatment of acne in people age 12 years and older. If pregnant or breast-feeding, ask doctor before use. Some other retinoid drugs have been shown to cause birth defects. There is no specific evidence that Differin Epiduo Acne Gel causes birth defects in humans when used topically as directed. Do not use Differin Epiduo Acne Gel if you are allergic to adapalene or any of the ingredients in this product, if you have very sensitive skin or if are you sensitive to benzoyl peroxide. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.. Apply Differin Epiduo Acne Gel only one time day and try to apply the product at the same time each day.. Gently clean the affected areas using mild (non-irritating) cleanser and pat dry.. Apply Differin Epiduo Acne Gel as thin layer to the affected areas of the skin only one time day. For example, if you get acne on the face, clean, dry and apply the product to the entire face. Differin Epiduo Acne Gel is not spot treatment and should not be used to treat single pimple. Avoid contact with eyes, lips and mouth. If contact occurs, immediately flush the area with water. Do not apply to damaged skin (cuts, abrasions, eczema, or sunburn). Wash hands after use.. It may take up to months of daily use for results to appear. Do not use more than one time day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.. When possible, limit sun exposure, including light from tanning beds. When going outdoors, use sunscreen as labeled. Your skin may be more sensitive while using Differin Epiduo Acne Gel. If you use Differin Epiduo Acne Gel during the day, allow it to dry before applying sunscreen.. Yes, use of moisturizer may help decrease dryness and other signs of irritation. Avoid 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.. Irritation (redness, itching, dryness, burning) is more likely to occur: In the first few weeks of use. if using abrasive skin cleansers, products with drying effects or more than one topical acne medication at time. You may want to delay starting Differin Epiduo Acne Gel until any irritation from using the other product(s) has gone away. in extreme weather such as wind and cold. In the first few weeks of use. if using abrasive skin cleansers, products with drying effects or more than one topical acne medication at time. You may want to delay starting Differin Epiduo Acne Gel until any irritation from using the other product(s) has gone away. in extreme weather such as wind and cold. Moisturizers may be used. Irritation usually lessens after weeks of continued use. If irritation gets wors, stop use and ask doctor before using Differin Epiduo Acne Gel again.. Do not use wax to remove hair in areas where Differin Epiduo Gel has been applied because it may worsen skin irritation.. Differin Epiduo Acne Gel contains:. Differin Epiduo Acne Gel should be stored at 20C to 25C (68 77F). Protect from freezing. Protect from light and keep away from heat. Do not use Differin Epiduo Acne Gel after the expiry date marked on the packaging.

OTC - ACTIVE INGREDIENT SECTION.

Drug Facts. Active ingredientAdapalene 0.1% (retinoid)read consumer information leafletBenzoyl Peroxide 2.5%.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if you use any other acne medicationshave any other skin or medical conditionsIf pregnant or breast-feeding, ask doctor before use.. use any other acne medications. have any other skin or medical conditions.

OTC - DO NOT USE SECTION.

Do not use. on damaged skin (cuts, abrasions, eczema, sunburn)if you are allergic to adapalene or any of the ingredients in this product.If you have very sensitive skinIf you are sensitive to benzoyl peroxide. on damaged skin (cuts, abrasions, eczema, sunburn). if you are allergic to adapalene or any of the ingredients in this product.. If you have very sensitive skin. If you are sensitive to benzoyl peroxide.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children.. If swallowed, get medical help or contact Poison Control Center right away.

OTC - PURPOSE SECTION.

Purpose. Acne treatment Acne treatment.

OTC - QUESTIONS SECTION.

Questions 1-866-735-4137.

OTC - STOP USE SECTION.

Stop use and ask doctor if. you become pregnant, or are planning to become pregnant, while using the productyou have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)irritation gets worseyou see no improvement after months of once daily use. you become pregnant, or are planning to become pregnant, while using the product. you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath). irritation gets worse. you see no improvement after months of once daily use. Keep out of reach of children.. If swallowed, get medical help or contact Poison Control Center right away.

OTC - WHEN USING SECTION.

When using this product. limit sun exposure, including light from tanning beds, and use sunscreen when going outdoorsdo not wax to remove hair in areas where the product has been appliedavoid contact with hair and dyed fabrics, which may be bleached by this productduring the early weeks of use, your acne may appear to worsen before it improves (this is normal)irritation (redness, itching, dryness, burning, peeling or possible swelling) is more likely to occur:in the first four weeks of useif using more than one topical acne medication at time If irritation occurs, it may be reduced:by using the product less frequentlyby using moisturizerby using only one topical acne medication at time it may take up to months of once daily use to see resultsavoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.wash hands after use. limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors. do not wax to remove hair in areas where the product has been applied. avoid contact with hair and dyed fabrics, which may be bleached by this product. during the early weeks of use, your acne may appear to worsen before it improves (this is normal). irritation (redness, itching, dryness, burning, peeling or possible swelling) is more likely to occur:in the first four weeks of useif using more than one topical acne medication at time in the first four weeks of use. if using more than one topical acne medication at time. If irritation occurs, it may be reduced:by using the product less frequentlyby using moisturizerby using only one topical acne medication at time by using the product less frequently. by using moisturizer. by using only one topical acne medication at time. it may take up to months of once daily use to see results. avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.. wash hands after use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 45g Carton (Pump). CONTAINS2 MEDICINESDIFFERIN(R)EPIDUOACNE GELADAPALENE 0.1% and BENZOYL PEROXIDE 2.5% GELACNE TREATMENTDUAL ACTION ACNE in CLEARING GELCombines two acne-clearing ingredientsPreviously available only by prescriptionDermatologist developed and testedOnce daily topical acne treatment Read consumer information leaflet before useNET WT 1.6 OZ (45 g)Easy pumpFirst FDA-approved over-the-counter dual active ingredient acne treatment.Read carton and enclosed consumer information leaflet before using this product. Keep this carton and consumer information leaflet. They contain important information.ACTUAL SIZEWater-based, oil-free gelFragrance freeGALDERMADistributed by:Galderma Laboratories, L.P.Fort Worth, TX 76177 USAAll trademarks are the property of their respective owners. Made in Canada www.differin.comNDC: 0299-4908-40PXXXXX-X.

SPL UNCLASSIFIED SECTION.

Other information. store at 20C to 25C (68F to 77F)protect from freezingprotect from light and keep away from heat. store at 20C to 25C (68F to 77F). protect from freezing. protect from light and keep away from heat.

WARNINGS SECTION.

Warnings. For external use only.