DIFFERIN EPIDUO- adapalene and benzoyl peroxide gel

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient
Adapalene 0.1% (retinoid)*
*read consumer information leaflet
Benzoyl Peroxide 2.5%

Purpose

Acne treatment

Acne treatment

Use

• For the treatment of acne

Warnings

For external use only

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 skin
• If you are sensitive to benzoyl peroxide

Ask a doctor or pharmacist before use if you

• use any other acne medications
• have any other skin or medical conditions

If pregnant or breast-feeding, ask a doctor before use.

When using this product

• 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 use
  • if using more than one topical acne medication at a time
• If irritation occurs, it may be reduced:
  • by using the product less frequently
  • by using moisturizer
  • by using only one topical acne medication at a time
• it may take up to 3 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

Stop use and ask doctor if

• 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 3 months of once daily use

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions Adults and children 12 years of age and older:

• use once daily
• clean the skin gently and pat dry before applying the product
• cover the entire affected area with a 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 a doctor.

• Children under 12 years of age: do not use

Other information

• store at 20°C to 25°C (68°F to 77°F)
• protect from freezing
• protect from light and keep away from heat

Inactive Ingredients

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

Questions? 1-866-735-4137

Patient Leaflet

DIFFERIN®
EPIDUO
ACNE GEL
ADAPALENE 0.1% and
BENZOYL PEROXIDE 2.5% GEL
ACNE TREATMENT

Frequently Asked Questions

What is Differin Epiduo Acne Gel and what is it used for?

• Differin Epiduo Acne Gel is a topical medication used for the treatment of acne in people age 12 years and older. 

What should I know before using Differin Epiduo Acne Gel?

• If pregnant or breast-feeding, ask a 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 a Poison Control Center right away.

How often do I apply Differin Epiduo Acne Gel?

• Apply Differin Epiduo Acne Gel only one time a day and try to apply the product at the same time each day.

How do I apply Differin Epiduo Acne Gel?

• Gently clean the affected areas using a mild (non-irritating) cleanser and pat dry.
• Apply Differin Epiduo Acne Gel as a thin layer to the affected areas of the skin only one time a 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 a spot treatment and should not be used to treat a 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 work?

• It may take up to 3 months of daily use for results to appear. 
• Do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.

What do I do if I need to be in the sun?

• When possible, limit sun exposure, including light from tanning beds. 
• When going outdoors, use a 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®
EPIDUO
ACNE GEL
ADAPALENE 0.1% AND
BENZOYL PEROXIDE 2.5% GEL
ACNE TREATMENT

Frequently Asked Questions (Continued)

Can I use a moisturizer if my skin is dry?

• Yes, use of a 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 I do?

• 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 a 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 4 weeks of continued use.
  

What do I do if my skin becomes severely irritated?

• If irritation gets wors, stop use and ask a doctor before using Differin Epiduo Acne Gel again.

Can I remove unwanted facial hair by waxing while using Differin Epiduo Acne Gel?

• Do 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 Gel?

• Differin 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 I store this Differin Epiduo Acne Gel?

• Differin Epiduo Acne Gel should be stored at 20°C to 25°C (68° – 77°F). 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 I get information?
Phone: 1-866-735-4137

See outer carton for complete warnings and information.


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PRINCIPAL DISPLAY PANEL - 45g Carton (Pump)

CONTAINS
2 MEDICINES

DIFFERIN®
EPIDUO
ACNE GEL

ADAPALENE 0.1% and 
BENZOYL PEROXIDE 2.5% GEL
ACNE TREATMENT

DUAL ACTION

ACNE 2 in 1 CLEARING GEL

Combines two acne-clearing ingredients

Previously available only by prescription

Dermatologist developed and tested

Once daily topical acne treatment*

* Read consumer information leaflet before use

NET WT 1.6 OZ (45 g)

Easy pump!

First 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 SIZE

Water-based, oil-free gel

Fragrance free

GALDERMA
Distributed by:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners.

Made in Canada

www.differin.com

NDC: 0299-4908-40

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INGREDIENTS AND APPEARANCE

DIFFERIN EPIDUO 
adapalene and benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4908
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	1 mg  in 1 g
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Acrylamide/Sodium Acryloyldimethyltaurate Copolymer (120000 Mpa.S At 1%) (UNII: 5F4963KLHS)
Docusate Sodium (UNII: F05Q2T2JA0)
Edetate Disodium (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Isohexadecane (UNII: 918X1OUF1E)
Poloxamer 124 (UNII: 1S66E28KXA)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sorbitan Monooleate (UNII: 06XEA2VD56)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4908-00	2 g in 1 TUBE; Type 0: Not a Combination Product	05/22/2026
2	NDC: 0299-4908-10	1 in 1 CARTON	05/22/2026
2		15 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 0299-4908-40	1 in 1 CARTON	05/22/2026
3		45 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA220736	05/22/2026

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(0299-4908)