DIFFERIN® EPIDUO ACNE GEL

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2026-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:38

Label at a glance#

ProductDifferin Epiduo
Active ingredientADAPALENE, Benzoyl Peroxide
Label structure12 sections

Dosage and administration

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 us...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Acne treatment

Acne treatment

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DirectionsAdults and children 12 years of age and older:

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Patient Leaflet

INFORMATION FOR PATIENTS SECTION

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.


PXXXXX-X

PRINCIPAL DISPLAY PANEL - 45g Carton (Pump)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PXXXXX-X

differin-epiduo-45g-carton
differin-epiduo-45g-carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelPSN1
2743622DIFFERIN EPIDUO 0.1 % / 2.5 % Topical GelPSN1
2743622adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Differin Epiduo]SBD1
829539adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical GelSCD1
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelSY1
2743622Differin Epiduo (adapalene 0.1 % / benzoyl peroxide 2.5 % ) Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADAPALENE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4908-00Differin Epiduo2 g in 1 TUBEGEL21
0299-4908-10Differin Epiduo15 g in 1 BOTTLE, PUMPGEL151
0299-4908-10Differin Epiduo1 in 1 CARTONGEL11
0299-4908-40Differin Epiduo45 g in 1 BOTTLE, PUMPGEL451
0299-4908-40Differin Epiduo1 in 1 CARTONGEL11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-49080299-4908-00, 0299-4908-10, 0299-4908-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220736-001DIFFERIN EPIDUOADAPALENE; BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALRLD, RS2026-05-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N220736-001DIFFERIN EPIDUO0.1%;2.5%GEL / TOPICALRLD, RS2026-05-22c2088c7a36db…
2026-09-14 22:38:342026-08N220736-001DIFFERIN EPIDUO0.1%;2.5%GEL / TOPICALRLD, RS2026-05-2284e616aacf4f…
2026-08-18 06:07:402026-07N220736-001DIFFERIN EPIDUO0.1%;2.5%GEL / TOPICALRLD, RS2026-05-22caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220736-001DIFFERIN EPIDUO0.1%;2.5%GEL / TOPICALRLD, RS2026-05-22a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Differin EpiduoADAPALENE AND BENZOYL PEROXIDEGalderma Laboratories, L.P.ae3f8cd9-9046-4b69-b80f-3e9d4468ba7f2026-05-20WarningsExact identifier
ndc (package): 0299-4908-00
ndc (package): 0299-4908-10
ndc (package): 0299-4908-40
ndc (product): 0299-4908
ndc11 (package): 00299490810
ndc11 (package): 00299490840
ndc11 (package): 00299490800
spl id: 30e41f9e-c736-40e3-bb96-df21c26d23fc
spl set id: ae3f8cd9-9046-4b69-b80f-3e9d4468ba7f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.