Home › NDC Lookup › Ingredients › Alclometasone Dipropionate › 68462-0299-47
Alclometasone Dipropionate .5 mg/g Ointment, 45 g — NDC 68462-0299-47 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Alclometasone Dipropionate .5 mg/g Ointment, 45 g — NDC 68462-299-47 (Billing 68462-0299-47)

by Glenmark Pharmaceuticals Inc., USA · 45 g in 1 TUBE

This is a package of 45 g of Alclometasone Dipropionate .5 mg/g Ointment from Glenmark Pharmaceuticals Inc., USA, marketed since Jul 2009 and currently FDA-listed; retail pharmacies pay about $1.23 per g (NADAC).

NDC 68462-0299-47
🏷️ FDA NDC (as labeled) 68462-299-47 billing pads the product segment with a zero
This package
Contains45 g Cost per g$1.23 NADAC Per package$55.43 / 45 g Pack sizes3 compare ↓
Also priced by: Part D plans $0.7397/unit — full pricing hub ↓
Product page 68462-0299-17 Also comes in: 15 g 68462-299-17 60 g 68462-299-65
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68462-299-47 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68462 labeler · 299 product · 47 package
Package marketed since
Jul 30, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
45 g per package
Barcode (UPC-A, from the NDC)
3 6846229947 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68462-299-47
Product NDC 68462-299
11-digit billing NDC 68462029947
NCPDP billing unit GM — per gram (weight)
RxCUI 855474, 855480
UNII S56PQL4N1V
Application # ANDA079227
SPL Set ID 63e635e0-65d8-4b30-9f2a-ab16deba90bd
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-07-30
Route TOPICAL
Dosage form OINTMENT
Substance ALCLOMETASONE DIPROPIONATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90550005104210
GPI class Alclometasone Dipropionate
GCN Seq No 007637
GCN 33730
HICL code 003328
Ingredient (HICL) Alclometasone Dipropionate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name ALCLOMETASONE DIPR 0.05% OINT
FDB brand name Alclometasone Dipropionate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007637
  • GCN: 33730
  • GPI-14 (Medi-Span): 90550005104210
  • HICL (First Databank): 003328
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 855474
Why two NDCs? The FDA registers this code as 68462-299-47 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68462-0299-47. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, moderately potent (group II), Corticosteroids, plain
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ALCLOMETASONE DIPR 0.05% OINT Ingredient Alclometasone Dipropionate

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer gPer package
Retail pharmacies payNADAC · weekly $1.232 $55.43 / 45 g
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.7397 $33.29 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Mar 2021 $1.232 $1.232
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
68462-0299-17 68462-299-17 Main listing 15 g in 1 TUBE $0.8031 / g $12.05 2009-07-30 — Active
68462-0299-47 You're viewing this 45 g in 1 TUBE $1.23 / g $55.43 2009-07-30 — Active
68462-0299-65 68462-299-65 60 g in 1 TUBE — — 2009-07-30 — Active

You're viewing one of 3 pack sizes for this product.

Per g, this pack runs about 53% above the cheapest pack (15 g, $0.8031 vs $1.23 NADAC).

Pack size FAQ

What quantity is in this package?
This package contains 45 g — 45 g in 1 tube.
How does this package differ from NDC 68462-0299-17?
Both are Alclometasone Dipropionate .5 mg/g Ointment — the drug itself is identical. This page's package is the 45 g one, while NDC 68462-0299-17 is the 15 g package. Per-g NADAC also differs: $1.23 here vs $0.8031 for the 15 g pack.
What NDC number is used to bill for this package of Alclometasone Dipropionate .5 mg/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alclometasone Dipropionate .5 mg/g 51672-1316-01 Sun 1 tube $0.861 AB Availability likely save 30%
Alclometasone Dipropionate .5 mg/g 00168-0263-15 E. 15 g $0.907 AB Discontinued save 26%
Alclometasone Dipropionate .5 mg/gthis 68462-0299-47 Glenmark 45 g $1.232 — FDA listed —
Alclometasone dipropionate .5 mg/g 51672-1306-01 Sun 1 tube $2.187 AB Availability likely +78%
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Jul 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII F76354LMGR
    A synthetic fatty acid compound derived from propylene glycol and palm oil. It works as an emulsifier to blend oil and water-based ingredients, and as a thickener to improve texture and stability in the medicine.
  • UNII 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA079227 (ANDA)
Labeler code68462
First marketedJul 2009
Product typeHuman Prescription Drug
Portfolio343 products on file

More NDCs from Glenmark Pharmaceuticals Inc., USA labeler code 68462

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 97 words ▾

INDICATIONS AND USAGE Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and 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: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

⏱️ Dosage and Administration 194 words ▾

DOSAGE AND ADMINISTRATION Apply a thin film of alclometasone dipropionate cream or ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream or 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. 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 cream or ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream or 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 cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

⛔ Contraindications 24 words ▾

CONTRAINDICATIONS Alclometasone dipropionate cream and ointment are contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.

🤒 Adverse Reactions 99 words ▾

ADVERSE REACTIONS The following local adverse reactions have been reported with alclometasone dipropionate cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes. 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.

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.

🤰 Pregnancy 67 words ▾

Pregnancy Teratogenic Effects 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.

Alclometasone dipropionate cream or ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use ~1 min read ▾

Pediatric Use Alclometasone dipropionate cream and ointment may be used with caution 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. Use of alclometasone dipropionate cream and ointment is supported by results from adequate and well-controlled studies in pediatric patients with corticosteroid-responsive dermatoses. Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, its use in this age-group is not recommended.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children.

Pediatric patients applying alclometasone dipropionate cream or ointment to >20% of the body surface area are at higher risk for HPA axis suppression. HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Alclometasone dipropionate cream or ointment should not be used in the treatment of diaper dermatitis.

🧓 Geriatric Use 95 words ▾

Geriatric Use A limited number of patients at or above 65 years of age have been treated with alclometasone dipropionate cream and ointment in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety. No adverse events were reported with alclometasone dipropionate ointment in geriatric patients, and the single adverse reaction reported with alclometasone dipropionate cream in this population was similar to those reactions reported by younger patients.

Based on available data, no adjustment of dosage of alclometasone dipropionate cream and ointment in geriatric patients is warranted.

🆘 Overdosage 21 words ▾

OVERDOSAGE Topically applied alclometasone dipropionate cream and ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Like other topical corticosteroids, alclometasone dipropionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier.

Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

A study utilizing a radio labeled alclometasone dipropionate ointment formulation was performed to measure systemic absorption and excretion. Results indicated that approximately 3% of the steroid was absorbed during 8 hours of contact with intact skin of normal volunteers. Studies performed with alclometasone dipropionate cream and ointment indicate that these products are in the low to medium range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 56 words ▾

HOW SUPPLIED Alclometasone Dipropionate Cream USP, 0.05% is supplied in: 15 gram tubes (NDC 68462-300-17) 45 gram tubes (NDC 68462-300-47) 60 gram tubes (NDC 68462-300-65) Alclometasone Dipropionate Ointment USP, 0.05% is supplied in: 15 gram tubes (NDC 68462-299-17) 45 gram tubes (NDC 68462-299-47) 60 gram tubes (NDC 68462-299-65) Store between 2°C and 30°C (36°F and 86°F).

📦 Storage and Handling 8 words ▾

Store between 2°C and 30°C (36°F and 86°F).

📋 Description 160 words ▾

DESCRIPTION Alclometasone Dipropionate Cream USP, 0.05% and Alclometasone Dipropionate Ointment USP, 0.05% contain alclometasone dipropionate, USP (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate, USP is C 28 H 37 ClO 7 .

It has the following structural formula: Alclometasone dipropionate, USP has the molecular weight of 521.04 g/mol. It is a white to almost white crystalline powder, sparingly soluble in alcohol, acetone, ethyl acetate and acetonitrile. Each gram of Alclometasone Dipropionate Cream USP contains 0.5 mg of alclometasone dipropionate, USP in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, mono and di-glycerides, PEG 100 stearate, ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water.

Each gram of Alclometasone Dipropionate Ointment USP contains 0.5 mg of alclometasone dipropionate, USP in an ointment base of hexylene glycol, white wax, propylene glycol monopalmitostearate, and white petrolatum. structure-formula

💬 Information for Patients 183 words ▾

Information for Patients Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes. 2. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician. 4.

Patients should report to their physician any signs of local adverse reactions. 5. Parents of pediatric patients should be advised not to use alclometasone dipropionate cream or ointment in the treatment of diaper dermatitis.

Alclometasone dipropionate cream or ointment should not be applied in the diaper area as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION ). 6. This medication should not be used on the face, underarms, or groin areas unless directed by the physician.

7. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. The effects of alclometasone dipropionate cream and ointment on the HPA axis have been evaluated. In one study, alclometasone dipropionate cream and ointment were applied to 30% of the body twice daily for 7 days, and occlusive dressings were used in selected patients either 12 hours or 24 hours daily.

In another study, alclometasone dipropionate cream was applied to 80% of the body surface of normal subjects twice daily for 21 days with daily 12-hour periods of whole body occlusion. Average plasma and urinary free cortisol levels and urinary levels of 17-hydroxysteroids were decreased (about 10%), suggesting suppression of the HPA axis under these conditions. Plasma cortisol levels have also been demonstrated to decrease in pediatric patients treated twice daily for 3 weeks without occlusion.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

For information on systemic supplementation, see prescribing information for those products. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface area to body mass ratios (see PRECAUTIONS: Pediatric Use ). If irritation develops, alclometasone dipropionate cream or ointment should be discontinued and appropriate therapy instituted.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.

If a favorable response does not occur promptly, use of alclometasone dipropionate cream or ointment should be discontinued until the infection has been adequately controlled. In a transgenic mouse study, chronic use of alclometasone dipropionate cream led to an increased number of animals with benign neoplasms of the skin at the treatment site (see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility ). The clinical relevance of the findings in animal studies to humans is not clear.

Information for Patients Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes. 2. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician. 4.

Patients should report to their physician any signs of local adverse reactions. 5. Parents of pediatric patients should be advised not to use alclometasone dipropionate cream or ointment in the treatment of diaper dermatitis.

Alclometasone dipropionate cream or ointment should not be applied in the diaper area as diapers or pl… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 70 words ▾

Nursing Mothers 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. Because many drugs are excreted in human milk, caution should be exercised when alclometasone dipropionate cream or ointment is administered to a nursing woman.

🧬 Pharmacokinetics 137 words ▾

Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin.

Inflammation and/or other disease processes in the skin may increase percutaneous absorption. A study utilizing a radio labeled alclometasone dipropionate ointment formulation was performed to measure systemic absorption and excretion. Results indicated that approximately 3% of the steroid was absorbed during 8 hours of contact with intact skin of normal volunteers.

Studies performed with alclometasone dipropionate cream and ointment indicate that these products are in the low to medium range of potency as compared with other topical corticosteroids.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 108 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of alclometasone dipropionate. The effects of alclometasone dipropionate on mutagenesis or fertility have not been evaluated. In a 26-week dermal carcinogenicity study conducted in transgenic (Tg.AC) mice, topical application once daily of both the vehicle cream and the 0.05% alclometasone dipropionate cream significantly increased the incidence of benign neoplasms of the skin in both sexes at the treatment site when compared to untreated controls.

This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.

📄 Package Label / Principal Display Panel 37 words ▾

PRINCIPAL DISPLAY PANEL NDC 68462-300-47 Alclometasone Dipropionate Cream USP, 0.05% For dermatologic use only – Not for ophthalmic use. cream-carton

NDC 68462-299-47 Alclometasone Dipropionate Ointment USP, 0.05% For dermatologic use only – Not for ophthalmic use ointment-carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Alclometasone Dipropionate — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Alclometasone Dipropionate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$167.6K
Claims incl. refills
3.3K
Beneficiaries
3K
Spend / beneficiary
$56.07
Spend / claim
$50.16
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 68462-0298-17 · Glenmark 68462-0301-47 · Glenmark →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.