SkinActive ingredient
Ivermectin
Topical antiparasitic and anti-inflammatory1 FDA label read
Soolantra is topical ivermectin, approved for the inflammatory lesions of rosacea. It is the same active ingredient as the oral antiparasitic medicine, formulated as a cream for the face and approved for a different purpose entirely.
Highlights of the labels
- Soolantra
- Inflammatory lesions of rosaceacovers skin
- Supply
- Prescription only
- Generic
- 10 approved applications
- 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 |
|---|---|---|---|
| SoolantraGalderma Laboratories, L.P. | What its label approvesInflammatory lesions of rosaceaCovers skin | SupplyPrescription | Label version24 October 2024 |
How it works
The approved label does not say how this cream works, in one short sentence quoted below. That gap gets filled elsewhere: ivermectin is used as an antiparasitic in other settings, and explanations involving skin mites circulate widely. None of that appears in the document the FDA reviewed, and this page does not repeat it as fact.
Mechanism of action, Soolantra label
The mechanism of action of SOOLANTRA cream in treating rosacea lesions is unknown.
What the FDA approved it for
The approved uses, as worded in the label.
SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.
Forms and strengths
The presentations and strengths listed in the label.
- Each gram of SOOLANTRA cream contains 10 mg of ivermectin in a white to pale yellow cream base.
- SOOLANTRA cream is supplied in tubes of 30 g, 45 g and 60 g.
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- Apply to the affected areas of the face once daily.
- Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected.
- Spread as a thin layer, avoiding the eyes and lips.
- SOOLANTRA cream is not for oral, ophthalmic, or intravaginal use.
- Apply to the affected areas once daily.
- Not for oral, ophthalmic or intravaginal use.
Most common adverse reactions
The adverse reactions the label reports as most common.
most common adverse reactions (incidence ≤ 1%) included skin burning sensation and skin irritation.
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.
In vitro studies have shown that SOOLANTRA cream, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
The available data on the use of ivermectin, including SOOLANTRA cream, in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant rats and rabbits during the period of organogenesis at doses 1909 or 354 times the maximum recommended human dose (MRHD), respectively.
Generic or brand
Topical ivermectin cream is approved as a generic in addition to the branded product.
The FDA label database lists 10 approved generic applications for this ingredient.
What affects the cost
This is a prescription cream, so cost depends on insurance and on whether a generic is dispensed. This site does not link to 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 | Generic |
|---|---|---|
| per gram | Brand$15.51 (range $15.51 to $15.52, 30 listings) | Generic$3.06 (range $1.14 to $3.25, 158 listings) |
Median of 188 listings. Effective dates 2025-12-17 to 2026-07-22, file dated 2026-07-29.
What the FDA has changed in these labels
The regulator reissues a label without notice: the old wording simply stops existing. These are the latest revisions on record for the documents this page is built from.
- 4 May 2018Soolantrafrom the archive
Adverse reactions (5 removed)
- 30 October 2017Soolantrafrom the archive
Adverse reactions (1 added)
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
- Is this the same ivermectin taken as tablets?
- The same active ingredient, but a separate approval, a separate label and a different route. The label on this page covers a cream applied to the face for rosacea. It says nothing about any oral use.
- Does the label explain how it works?
- No. It states that the mechanism of action in treating rosacea lesions is unknown. Its contraindications section likewise says none, and this page reports both rather than filling the gaps with explanations from elsewhere.
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 Soolantra
Galderma Laboratories, L.P.. Label version 8, effective 24 October 2024.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 23 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.