Medicine guide

Differin

3 mg/g · Gel

Prescription only
Retinoid

Active substance: Adapalene
Used in: Skin
Made by: Galderma Laboratories, L.P.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-12-27

What it is

Retinoid

Used for

DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. DIFFERIN Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12…

Do not take it if

DIFFERIN Gel is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of DIFFERIN Gel [ see WARNINGS AND PRECAUTIONS (5.1) ].

All warnings ↓

Good to know

Prescription only
Mediclarum could not reach the FDA to check for recalls just now. This is not a result.

37other products contain Adapalene — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. DIFFERIN Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )

From the official label · 2023-12-27 · DailyMed

How it works

From this product’s own US prescribing label.

Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein.
Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes.

Half-life7–51 h

Mostly cleared after≈ 6 daysfive half-lives — our arithmetic

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-12-27

Do not take it if

DIFFERIN Gel is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of DIFFERIN Gel [ see WARNINGS AND PRECAUTIONS (5.1) ].
Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of DIFFERIN Gel.
( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Wash affected areas gently with a non-medicated soap.
Apply a thin film of DIFFERIN Gel to the entire face and any other affected areas of the skin once daily in the evening.
Avoid application to the areas of skin around eyes, lips, and mucous membranes.
A mild transitory sensation of warmth or slight stinging may occur shortly after the application of DIFFERIN Gel.
Instruct patients to minimize sun exposure and to use moisturizers for relief of dry skin or irritation.
If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated.
For topical use only.
Not for ophthalmic, oral or intravaginal use.
Wash affected areas gently with a non-medicated soap.
( 2 ) Apply a thin film of DIFFERIN Gel, to the entire face and other affected areas of the skin once daily in the evening.
( 2 ) For topical use only.
Not for ophthalmic, oral or intravaginal use.
( 2 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Allergic/ Hypersensitivity Reactions:
Allergy/hypersensitivity reactions include anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritis.
Discontinue DIFFERIN Gel in the event of an allergic/hypersensitivity reaction.( 5.1 ) Ultraviolet Light and Environmental Exposure:
Avoid exposure to sunlight and sunlamps.
Wear sunscreen when sun exposure cannot be avoided ( 5.2 ).
Local Cutaneous Reactions:
Erythema, scaling, dryness, and stinging/burning were reported with use of DIFFERIN Gel.
Concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution.
( 5.3 ).
5.1 Allergic/ Hypersensitivity Reactions Adverse reactions including anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritus that sometimes required medical treatment have been reported during postmarketing use of adapalene.
Advise a patient to stop using DIFFERIN Gel and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment.
5.2 Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during use of DIFFERIN Gel.
Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution.
Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.
Weather extremes, such as wind or cold, also may be irritating to patients under treatment with DIFFERIN Gel.
5.3 Local Cutaneous Reactions Cutaneous signs and symptoms such as erythema, scaling, dryness, and stinging/burning were reported with use of DIFFERIN Gel.
These were most likely to occur during the first four weeks of treatment, were mostly mild to moderate in intensity, and usually lessened with continued use of the medication.
Depending upon the severity of these side effects, patients should be instructed to either use a moisturizer, reduce the frequency of application of DIFFERIN Gel or discontinue use.
Avoid application to cuts, abrasions, eczematous or sunburned skin.
As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with adapalene.
As DIFFERIN Gel has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Available data from clinical trials with DIFFERIN Gel use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations ( see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.
In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.
Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the MRHD based on a mg/m² comparison.
However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m² comparison).
Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits.
Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary Available data from clinical trials with DIFFERIN Gel use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations ( see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.
In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.
Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the MRHD based on a mg/m² comparison.
However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m² comparison).
Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits.
Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).
8.2 Lactation Risk Summary There are no data on the presence of topical adapalene gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
In animal studies, adapalene is present in rat milk with oral administration of the drug.
When a drug is present in animal milk, it is likely that the drug will be present in human milk.
It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk ( see Clinical Considerations ).
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DIFFERIN Gel and any potential adverse effects on the breastfed child from DIFFERIN Gel, or from the underlying maternal condition.
Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, 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.
8.4 Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12.
8.5 Geriatric Use Clinical studies of DIFFERIN Gel did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects.
Safety and effectiveness in geriatric patients age 65 and above have not been established.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness have not been established in pediatric patients below the age of 12.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of DIFFERIN Gel did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.

Quoted from the official label, section “Geriatric Use”.

Side effects

The most frequently reported (≥ 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used DIFFERIN Gel once daily for 12 weeks.
Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter.
The incidence of local cutaneous irritation with DIFFERIN Gel from the controlled clinical trial is provided in the following table:
Table 1:
Physician assessed local cutaneous irritation with DIFFERIN Gel Incidence of Local Cutaneous Irritation with DIFFERIN Gel (N = 253*) Maximum Severity Scores Higher Than Baseline Mild Moderate Severe Erythema 66 (26.1%) 33 (13.0%) 1 (0.4%) Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%) Dryness 113 (44.7%) 43 (17.0%) 2 (0.8%) Burning/Stinging 72 (28.5%) 36 (14.2%) 9 (3.6%) * Total number of subjects with local cutaneous data for at least one post-Baseline evaluation Table 2:
Patient reported local cutaneous reactions with DIFFERIN Gel DIFFERIN (adapalene) Gel Vehicle Gel N = 258 N = 134 Related* Adverse Reactions Dry Skin Skin Discomfort Desquamation 57 (22.1%) 36 (14%) 15 (5.8%) 4 (1.6%) 6 (4.5%) 2 (1.5%) 0 (0%) 0 (0%) * Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related The following adverse reactions occurred in less than 1% of subjects:
acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
In a one-year, open-label safety trial of 551 subjects with acne who received DIFFERIN Gel, the pattern of adverse reactions was similar to the 12-week controlled study.
6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of adapalene:
Immune system disorders:
angioedema, face edema, lip swelling Skin disorders:
application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

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:
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.
Avoid contact with the eyes, lips, angles of the nose, and mucous membranes Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.
This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin.
Wax depilation should not be performed on treated skin due to the potential for skin erosions.
Minimize exposure to sunlight including sunlamps.
Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.
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.
This product is for external use only.
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) ] Marketed by:
GALDERMA LABORATORIES, L.P., Dallas, TX 75201 USA Manufactured by:G Production Inc., Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada.
GALDERMA is a registered trademark.
P52321-X

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Each gram of DIFFERIN Gel, 0.3% contains 3 mg adapalene in an off-white aqueous gel. Gel, 0.3% ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

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

Quoted from the official label, section “How Supplied”.

What is in it

DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide.
May contain hydrochloric acid for pH adjustment.
The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid.
It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water.
The molecular formula is C 28 H 28 O 3 and molecular weight is 412.53.
Adapalene is represented by the following structural formula.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (6)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 6 of 6

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (4)

Details

Made by	Galderma Laboratories, L.P.
Active substance	Adapalene
Used in	Skin
Strength	3 mg/g
Form	Gel
Route	Topical
Packs	1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP
NDC	0299-5918

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Gel2 products
- 1 mg/g
- 3 mg/g

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Adapalene1 mg/gPrescription onlyCream E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC · Adapalene Adapalene1 mg/gWithout prescriptionGel Walgreens · Adapalene Adapalene3 mg/gPrescription onlyGel Actavis Pharma, Inc. · Adapalene Adapalene1 mg/gWithout prescriptionGel RUGBY LABORATORIES, INC. · Adapalene Adapalene1 mg/gWithout prescriptionGel RITE AID · Adapalene Adapalene1 mg/gWithout prescriptionGel Safeway, Inc. · Adapalene

See every product with Adapalene