Quick answers
- What is Alclometasone dipropionate used for?
- The FDA-approved label (Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., August 13, 2025) says: “Alclometasone Dipropionate Ointment USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Alclometasone dipropionate?
- The “Adverse Reactions” section of the FDA label (Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., August 13, 2025) begins: “The following local adverse reactions have been reported with alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alclometasone dipropionate have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Alclometasone dipropionate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alclometasone dipropionate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Alclometasone dipropionate?
- 2 companies list prescription products of Alclometasone dipropionate in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc. and Glenmark Pharmaceuticals Inc., USA.
What Alclometasone dipropionate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Alclometasone Dipropionate Ointment USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS …
— FDA label: Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., effective August 13, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (ointment, topical), Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Alclometasone dipropionate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following local adverse reactions have been reported with alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings.
Read more of this section
These reactions are listed in approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., effective August 13, 2025. Read the full label on DailyMed →
Alclometasone dipropionate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Apply a thin film of Alclometasone Dipropionate Ointment USP, 0.05% to the affected skin areas two or three times daily; massage gently until the medication disappears. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.
Read more of this section
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Alclometasone dipropionate ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing. Geriatric Use In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with alclometasone dipropionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
— FDA label: Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., effective August 13, 2025. Read the full label on DailyMed →
Alclometasone dipropionate in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women.
Read more of this section
Alclometasone dipropionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
— FDA label: Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., effective August 13, 2025. Read the full label on DailyMed →
Alclometasone dipropionate and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of topical corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
Read more of this section
Because many drugs are excreted in human milk, caution should be exercised when alclometasone dipropionate ointment is administered to a nursing woman.
— FDA label: Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., effective August 13, 2025. Read the full label on DailyMed →
When Alclometasone dipropionate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Alclometasone Dipropionate Ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in this preparation.
— FDA label: Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., effective August 13, 2025. Read the full label on DailyMed →
Alclometasone dipropionate overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Topically applied alclometasone dipropionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
— FDA label: Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., effective August 13, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Ointment · Cream |
|---|---|
| Route | Topical |
| Prescription products | 3 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| alclometasone dipropionate 0.05% cream | Generic | $1.16–$2.17 per gram 3 packages, lowest to highest |
| alclometasone dipropionate 0.05% ointment | Generic | $0.5077–$0.8405 per gram 3 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sun Pharmaceutical Industries, Inc.2 products
- Glenmark Pharmaceuticals Inc., USA1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA076730Sun Pharma Canada · July 29, 2004
- ANDA076587Sun Pharma Canada · September 15, 2005
- ANDA079227Glenmark Pharms Ltd · July 30, 2009
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 855474, 855480 |
|---|---|
| SPL set ID of the quoted label | 3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c |
| FDA labels (SPL) | 3 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | ALCLOMETASONE DIPROPIONATE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Sun Pharmaceutical Industries, Inc.Maker or distributor
- Glenmark Pharmaceuticals Inc., USAMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Alclometasone Dipropionate, Sun Pharmaceutical Industries, Inc., effective August 13, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →