ADAPALENE 3 mg/g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Retinoid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Adapalene is used to treat acne in adults and children 12 years of and older. Adapalene is in a class of medications called retinoid-like compounds. It works by stopping pimples from forming under the surface of the skin.
Read the full MedlinePlus article ↗- Most people start to see meaningful improvement after 8 to 12 weeks of consistent use. In the early weeks, your acne might actually look a little worse before it gets better — this...
- How long does it take for adapalene to clear up my acne?
- Yes, redness, dryness, flaking, and mild stinging are the most common side effects, especially in the first few weeks. They're usually mild to moderate and tend to get better as yo...
- My skin is really red and dry after starting adapalene — is that normal?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII 1S66E28KXA
Poloxamer 124 is a synthetic polymer that acts as a surfactant and solubilizer in medicines. It helps dissolve and stabilize active ingredients, particularly in liquid formulations and gels.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.509 | $22.92 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $0.8137 | $36.62 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $0.9380 | $42.21 / 45 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| adapalene 3 mg/g 00472-0126-45 | Actavis | 1 tube | $0.509 | AB | Availability likely | — |
| Adapalene Gel USP, 0.3% 3 mg/g 21922-0051-06 | Encube | 1 tube | $0.509 | AB | Availability likely | — |
| Adapalene 3 mg/g 51672-1377-06 | Sun | 1 tube | $0.509 | AB | Availability likely | — |
| Adapalene 3 mg/gthis 68308-0666-25 | Mayne | 1 tube | $0.509 | AB | Availability likely | — |
| Differin 3 mg/g 00299-5918-02 | Galderma | 2 g | — | AB | Discontinued | — |
| Adapalene 3 mg/g 46708-0549-15 | Alembic | 1 tube | — | AB | FDA listed | — |
| Adapalene 3 mg/g 62332-0549-15 | Alembic | 1 tube | — | AB | FDA listed | — |
| Adapalene Gel USP, 0.3% 3 mg/g 72162-2295-02 | Bryant | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68308-0666-25 You're viewing this | 1 TUBE in 1 CARTON (68308-666-25) / 45 g in 1 TUBE | $0.5094 / g | $22.92 | 2024-02-26 | Active |
| 68308-0666-45 | 1 BOTTLE, PUMP in 1 CARTON (68308-666-45) / 45 g in 1 BOTTLE, PUMP | $0.7822 / g | $35.20 | 2024-02-26 | Active |
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.5094 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 98% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 68308-0666-25?
What NDC number is used to bill for this package of ADAPALENE 3 mg/g Gel?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Adapalene Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Wash affected areas gently with a non-medicated soap. Apply a thin film of Adapalene 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 Adapalene 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 Adapalene 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)
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Each gram of Adapalene Gel, 0.3% contains 3 mg adapalene in an off-white aqueous gel. Gel, 0.3% ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Adapalene Gel is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel [see WARNINGS AND PRECAUTIONS (5.1)]. Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Allergic/Hypersensitivity Reactions: Allergy/hypersensitivity reactions include anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritis. Discontinue Adapalene 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 Adapalene 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).
5.1Allergic/ 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 Adapalene Gel and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment..
5.2Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during use of Adapalene 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 Adapalene Gel.
5.3Local Cutaneous Reactions Cutaneous signs and symptoms such as erythema, scaling, dryness, and stinging/burning were reported with use of Adapalene 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 Adapalene 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 Adapalene 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most frequently reported ( > 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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 Adapalene 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 Adapalene Gel from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene Gel * Total number of subjects with local cutaneous data for at least one post-Baseline evaluation. Incidence of Local Cutaneous Irritation with Adapalene 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%) Table 2: Patient reported local cutaneous adverse reactions with Adapalene Gel * Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related 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%) 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 Adapalene Gel, the pattern of adverse reactions was similar to the 12-week controlled study.
6.2Postmarketing 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from clinical trials with Adapalene 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/m 2 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/m 2 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).
8.2Lactation 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 Adapalene Gel and any potential adverse effects on the breastfed child from Adapalene Gel, or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use Adapalene Gel on the smallest area of skin and for the shortest duration possible while breastfeeding.
Avoid application of Adapalene Gel to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child.
8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12.
8.5Geriatric Use Clinical studies of Adapalene 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.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from clinical trials with Adapalene 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/m 2 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/m 2 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).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Adapalene 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.
🆘 Overdosage ▾
10 OVERDOSAGE Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.
12.2Pharmacodynamics Clinical pharmacodynamic studies have not been conducted for Adapalene Gel.
12.3Pharmacokinetics Systemic exposure of adapalene following topical application of Adapalene Gel was evaluated in a clinical trial. Sixteen acne subjects were treated once daily for 10 days with 2 grams of Adapalene Gel applied to the face, chest and back, corresponding to approximately 2 mg/cm 2 . Fifteen subjects had quantifiable (LOQ = 0.1 ng/mL) adapalene levels resulting in a mean C max of 0.553 ± 0.466 ng/mL on Day 10 of treatment.
The mean AU CO-24hr was 8.37 ± 8.46 ng.h/mL as determined in 15 of the 16 subjects on Day 10. The terminal apparent half-life, determined in 15 of 16 subjects, ranged from 7 to 51 hours, with a mean of 17.2 ± 10.2 hours. Adapalene was rapidly cleared from plasma and was not detected 72 hours after the last application for all but one subject.
Exposure of potential circulating metabolites of adapalene was not measured. Excretion of adapalene appears to be primarily by the biliary route. In another clinical trial in subjects with moderate to moderately severe acne, Adapalene Gel, 0.3% or Adapalene Gel, 0.1 % was applied to the face and optionally to the trunk, once daily for 12 weeks.
Seventy-eight (78) subjects had plasma adapalene levels evaluated at Weeks 2, 8, and 12. Of the 209 plasma samples analyzed, adapalene concentrations were below the limit of detection (LOQ = 0.15 ng/mL) of the method in all samples but three. For the three samples, traces of adapalene below the limit of quantification (LOQ = 0.25 ng/mL) of the method were found.
One of these samples was taken at Week 12 from a male subject treated with Adapalene Gel, 0.3% who treated the face and the trunk for eight weeks (thereafter, only the face was treated). The second and third samples were from the Week 2 and 12 visits of a female subject treated with Adapalene Gel, 0.1 % who treated only the face for 12 weeks. In this study, the average daily usage of product was 1 g/day.
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/ STORAGE AND HANDLING Adapalene Gel, 0.3% is supplied in the following size. 45g tube – NDC 68308-666-25 45g pump – NDC 68308-666-45 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.
📋 Description ▾
11 DESCRIPTION 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 0 3 and molecular weight is 412.53. Adapalene is represented by the following structural formula. adap-gel-chem-struct
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Information for Patients Patients using Adapalene Gel should receive the following information and instructions: Apply a thin film of Adapalene Gel to the entire face and any other affected areas of the skin once daily in the evening. Apply a thin film of Adapalene 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 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 Adapalene Gel on the smallest area of the skin and for the shortest duration possible while breastfeeding. Avoid application of Adapalene 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) ].
Distributed by: Mayne Pharma Raleigh, NC 27609 Product of Canada. All trademarks are the property of their respective owners. P57305-X