Alclometasone Dipropionate .5 mg/g Cream, 15 g
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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.
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UNII I835H2IHHX
A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII 36W53O7109
Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
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UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
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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.
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UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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UNII TVH7653921
A synthetic polymer derived from ethylene glycol that acts as a humectant and solvent in medicines. It helps keep the product moist and aids in dissolving or dispersing active ingredients throughout the formulation.
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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.
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UNII 3980JIH2SW
A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
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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.
10 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 | $0.907 | $13.60 / 15 g |
| Medicaid paysCMS SDUD · 12 mo | $1.42 | $21.34 / 15 g |
| Medicare drug plans payPart D · Q2 2026 | $1.44 | $21.64 / 15 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Alclometasone Dipropionate .5 mg/g 68462-0299-17 | Glenmark | 15 g | $0.803 | — | FDA listed | save 11% |
| Alclometasone Dipropionate .5 mg/g 51672-1316-01 | Sun | 1 tube | $0.896 | AB | Availability likely | save 1% |
| Alclometasone Dipropionate .5 mg/gthis 00168-0263-15 | E. | 15 g | $0.907 | AB | FDA listed | — |
| Alclometasone dipropionate .5 mg/g 51672-1306-01 | Sun | 1 tube | $2.204 | AB | Availability likely | +143% |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ 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 |
|---|---|---|---|---|---|
| 00168-0263-15 You're viewing this | 15 g in 1 TUBE (0168-0263-15) | $0.9066 / g | $13.60 | 2005-07-12 | Active |
| 00168-0263-45 | 45 g in 1 TUBE (0168-0263-45) | $0.7247 / g | $32.61 | 2005-07-12 | Active |
| 00168-0263-60 | 60 g in 1 TUBE (0168-0263-60) | $1.25 / g | $74.89 | 2005-07-12 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Per g, this pack runs about 25% above the cheapest pack (45 g, $0.7247 vs $0.9066 NADAC).
This pack accounts for about 6.9% of this product's recent Medicaid fills; most go to the 60 gs pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 00168-0263-15?
What is the difference between NDC 00168-0263-15 and NDC 00168-0263-45?
What NDC number is used to bill for this package of Alclometasone Dipropionate .5 mg/g Cream?
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 ▾
INDICATIONS AND USAGE: Alclometasone dipropionate cream is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream 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 have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Apply a thin film of alclometasone dipropionate cream to the affected skin areas two or three times daily; massage gently until the medication disappears. Alclometasone dipropionate cream may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream 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 should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream 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, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
⛔ Contraindications ▾
CONTRAINDICATIONS: Alclometasone dipropionate cream is contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: The following local adverse reactions have been reported with alclometasone dipropionate cream in approximately 2% of patients: itching, burning, erythema, dryness, irritation, and papular rashes. 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.
🧒 Pediatric Use ▾
Pediatric Use: Alclometasone dipropionate cream 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 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 has 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's 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 to >20% of the body surface area are at higher risk for HPA axis suppression. HPA axis suppression, Cushing's 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 should not be used in the treatment of diaper dermatitis.
🧓 Geriatric Use ▾
Geriatric Use: A limited number of patients at or above 65 years of age have been treated with alclometasone dipropionate cream in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety. A 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 in geriatric patients is warranted.
Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with alclometasone dipropionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
🆘 Overdosage ▾
OVERDOSAGE: Topically applied alclometasone dipropionate cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
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 cream 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 indicate that this product is in the low to medium range of potency as compared with other topical corticosteroids.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Alclometasone dipropionate cream USP, 0.05% is supplied in 15 gram tube NDC 0168-0263-15 45 gram tube NDC 0168-0263-45 60 gram tube NDC 0168-0263-60 Store between 2° and 30‑°C (36° and 86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I2263D R08/12 #69
📋 Description ▾
DESCRIPTION: Alclometasone dipropionate cream contains alclometasone dipropionate (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 is C 28 H 37 ClO 7 .
It has the following structural formula: Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol. Each gram of alclometasone dipropionate cream contains 0.5 mg of alclometasone dipropionate in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetostearyl alcohol, glyceryl monostearate, PEG 100 stearate, ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water. structure.jpg
💬 Information for Patients ▾
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 in the treatment of diaper dermatitis.
Alclometasone dipropionate cream 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.