SkinActive ingredient
Trifarotene
Retinoid1 FDA label read
Trifarotene is sold as Aklief and is the newest retinoid on these pages, with two distinctions written into its label: approval from 9 years of age - the youngest in this category - and dosing instructions that cover the trunk, not only the face.
Highlights of the labels
- Aklief
- Acne in patients 9 and oldercovers skin
- Supply
- Prescription only
- Generic
- None approved
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| AkliefGalderma Laboratories, L.P. | What its label approvesAcne in patients 9 and olderCovers skin | SupplyPrescription | Label version16 September 2024 |
How it works
Trifarotene is an agonist of retinoic acid receptors with particular activity at the gamma subtype, the RAR most common in skin. The label's application instructions are counted in pump actuations: one for the face, two for the upper trunk.
Mechanism of action, Aklief label
Trifarotene is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR. Stimulation of RAR results in modulation of target genes which are associated with various processes, including cell differentiation and mediation of inflammation. The exact process by which trifarotene ameliorates acne is unknown.
What the FDA approved it for
The approved uses, as worded in the label.
AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Forms and strengths
The presentations and strengths listed in the label.
- Cream: 0.005%.
- Each gram of AKLIEF Cream contains 50 mcg of trifarotene in a white cream.
- Cream: 0.005% trifarotene.
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, and chin).
- Two actuations of the pump should be enough to cover the upper trunk (i.e., reachable upper back, shoulders and chest).
- One additional pump actuation may be used for middle and lower back if acne is present.
- The use of a moisturizer is recommended as frequently as needed from the initiation of treatment.
- Avoid contact with the eyes, lips, paranasal creases, mucous membranes.
- AKLIEF Cream is for topical use only.
Most common adverse reactions
The adverse reactions the label reports as most common.
- Most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus, and sunburn.
- most common adverse reactions (≥1% of subjects) for the entire trial were application site pruritus (4.6%), application site irritation (4.2%), and sunburn (5.5%).
Warnings and precautions
The warnings and precautions section of the label.
- Skin irritation: Erythema, scaling, dryness, and stinging/burning may be experienced with use of AKLIEF Cream. Use a moisturizer from the initiation of treatment, and, if appropriate, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use.
- Ultraviolet Light and Environmental Exposure: Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.
Contraindications
Situations in which the label states the medication must not be used.
None. The label states that there are no contraindications.
Drug interactions
Interactions the label singles out.
Topical application of AKLIEF Cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinyl estradiol and levonorgestrel.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Available data from clinical trials with AKLIEF Cream use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are case reports of major birth defects similar to those seen in fetuses exposed to oral retinoids in pregnant women exposed to other topical retinoids, but these case reports do not establish a pattern or association with retinoid-related embryopathy.
Generic or brand
There is no FDA-approved generic trifarotene: the register lists the brand application only.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Aklief is brand-only. Older retinoids on these pages - adapalene and tretinoin - have inexpensive generics, and that difference is visible across the pricing tables of this category. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand |
|---|---|
| per gram | Brand$16.34 (range $16.20 to $16.36, 34 listings) |
Median of 34 listings. Effective dates 2026-01-01 to 2026-08-19, file dated 2026-08-26.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- How is Aklief different from Differin?
- Both are retinoids for acne. Aklief is trifarotene, a prescription cream selective for one retinoic acid receptor subtype, approved from age 9, with label instructions for the trunk as well as the face. Differin is adapalene, and its 0.1% gel is sold over the counter. The comparison page reads both documents side by side.
- From what age is Aklief approved?
- From 9 years of age - the youngest approval among the acne medications on these pages.
- What does the label warn about?
- Skin irritation - erythema, scaling, dryness, stinging and burning - and sun sensitivity, with advice to minimize exposure to sunlight and sunlamps and use sunscreen. The full wording is quoted on this page.
Other medications under skin
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Aklief
Galderma Laboratories, L.P.. Label version 7, effective 16 September 2024.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.