Impoyz clobetasol propionate .25 mg/g Cream
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Clobetasol topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various scalp and skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Clobetasol is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗- Yes — clobetasol is classified as a super-high potency steroid, which puts it in the strongest category of topical corticosteroids available. It's used for stubborn inflammatory sk...
- What is clobetasol used for, and is it really that much stronger than other steroid creams?
- Apply it to a dry scalp — not wet hair — in a thin film over the affected areas only. Leave it on for 15 minutes, then add water, lather, and rinse everything thoroughly, including...
- How do I use the shampoo version correctly?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:
Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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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 NMQ347994Z
Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
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UNII A1A1I8X02B
A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
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UNII FCZ5MH785I
A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
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UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII YD01N1999R
A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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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.
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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.
11 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?
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💲 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Impoyz .25 mg/gthis 68040-0713-38 | Primus | 1 tube | — | — | FDA listed | — |
| Clobetasol Propionate .25 mg/g 74157-0710-10 | INA | 1 tube | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10064875 ↗ | Method of use | U-88 | Aug 31, 2030 |
| US 10064875 ↗ | Method of use | U-1858 | Aug 31, 2030 |
| US 9956231 ↗ | Method of use | U-88 | Aug 31, 2030 |
| US 10064875 ↗ | Method of use | U-193 | Aug 31, 2030 |
| US 10064875 ↗ | Method of use | U-1408 | Aug 31, 2030 |
| US 9956231 ↗ | Method of use | U-1408 | Aug 31, 2030 |
| US 9956231 ↗ | Method of use | U-193 | Aug 31, 2030 |
| US 9956231 ↗ | Method of use | U-742 | Aug 31, 2030 |
| US 9956231 ↗ | Method of use | U-1858 | Aug 31, 2030 |
| US 10064875 ↗ | Method of use | U-742 | Aug 31, 2030 |
| US 11179465 ↗ | Method of use | U-1858 | Aug 31, 2030 |
| US 10588914 ↗ | Method of use | U-2771 | Aug 31, 2030 |
| US 9956231 ↗ | Method of use | U-1761 | Aug 31, 2030 |
| US 9855334 ↗ | Drug product | — | Mar 11, 2035 |
Is there a generic version of IMPOYZ 0.025% CREAM?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68040-0713-38 You're viewing this | 1 TUBE in 1 CARTON (68040-713-38) / 100 g in 1 TUBE | 2021-12-01 | Active |
| 68040-0713-44 | 20 TUBE in 1 CARTON (68040-713-44) / 2.5 g in 1 TUBE | 2021-12-01 | Active |
Pack size FAQ
What quantity is in NDC 68040-0713-38?
What NDC number is used to bill for this package of Impoyz clobetasol propionate .25 mg/g Cream?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE IMPOYZ Cream 0.025% is indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. IMPOYZ Cream is a corticosteroid indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin layer of IMPOYZ Cream to the affected skin areas twice daily and rub in gently and completely. Use IMPOYZ Cream for up to 2 consecutive weeks of treatment. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic pituitary adrenal (HPA) axis [see Warnings and Precautions (5.1) ].
Discontinue IMPOYZ Cream when control is achieved. Do not use if atrophy is present at the treatment site. Do not bandage, cover, or wrap the treated skin area unless directed by a physician.
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. IMPOYZ Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Wash hands after each application. Apply a thin layer of IMPOYZ Cream to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application.
Use IMPOYZ Cream for up to 2 consecutive weeks of treatment. ( 2 ) Discontinue IMPOYZ Cream when control is achieved. ( 2 ) The total dosage should not exceed 50 g per week.
( 2 ) Do not use if atrophy is present at the treatment site. ( 2 ) Do not bandage, cover, or wrap the treated skin areas unless directed by a physician. ( 2 ) Avoid use on the face scalp, axilla, groin, or other intertriginous areas.
( 2 ) IMPOYZ Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Cream, 0.025% each gram contains 0.25 mg of clobetasol propionate in a white to off-white cream base. Cream, 0.025% ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Clobetasol propionate has been shown to suppress the HPA axis at the dose tested. ( 5.1 ) Cushing’s syndrome, hyperglycemia, and glucosuria can also result from systemic absorption of topical corticosteroids. ( 5.1 ) Systemic absorption may require periodic evaluation for HPA axis suppression.
Modify use if HPA axis develops. ( 5.1 ) Children may be more susceptible to systemic toxicity from use of topical corticosteroids. ( 5.1 , 8.4 ) Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings, prolonged use, or use of higher potency corticosteroids, including clobetasol propionate.
These reactions include; irritation, dryness, acneiform eruptions, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. ( 5.1 , 6.2 )
5.1Effects on the Endocrine System IMPOYZ Cream can cause reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Because of the potential of systemic absorption, use of topical corticosteroids, including IMPOYZ Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression.
Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of IMPOYZ Cream on the HPA axis, subjects with plaque psoriasis applied IMPOYZ Cream twice daily to at least 20% of involved Body Surface Area (BSA) for 15 days.
Abnormal ACTH stimulation tests suggestive of HPA axis suppression were seen in 3 of 24 (12.5%) subjects on IMPOYZ Cream [see Clinical Pharmacology (12.2) ]. In another trial to evaluate the effects of IMPOYZ Cream on the HPA axis, subjects with moderate to severe plaque psoriasis applied IMPOYZ Cream twice daily to at least 25% of involved BSA for 28 consecutive days. Abnormal ACTH stimulation test suggestive of HPA axis suppression was seen in 8 of 26 (30.8%) of subjects on IMPOYZ Cream.
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.
Minimize the unwanted risks from endocrine effects by mitigating risk factors favoring increased systemic bioavailability and by using the product as recommended [see Dosage and Administration (2) ]. Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ].
5.2Local Adverse Reactions with Topical Corticosteroids Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including IMPOYZ Cream. Some local adverse re…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reaction (incidence ≥ 1%) is application site discoloration. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Primus Pharmaceuticals Inc. at 480-483-1410 or FDA at 1-800-FDA-1088 or www. FDA.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. IMPOYZ Cream was evaluated in two randomized, multicenter, prospective, vehicle-controlled clinical trials in subjects with moderate to severe plaque psoriasis. Subjects applied IMPOYZ Cream or vehicle cream twice daily for 14 days.
A total of 354 subjects applied IMPOYZ Cream and 178 subjects applied vehicle. The adverse reaction that occurred in at least 1% of subjects treated with IMPOYZ Cream and at a higher incidence than in subjects treated with vehicle cream was application site discoloration (2% versus 1%). Less common local adverse events occurring in < 1% of subjects treated with IMPOYZ Cream were application site atrophy, telangiectasia and rash.
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of clobetasol propionate: striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis and miliaria. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on IMPOYZ Cream in pregnant women to inform a drug-associated risk for adverse development outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroids during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use IMPOYZ Cream on the smallest area of skin and for the shortest duration possible (see Data ).
In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparisons of animal exposure with human exposure are provided due to minimal systemic exposure noted after topical administration of IMPOYZ Cream [see Clinical Pharmacology (12.3) ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk or birth defect loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality.
However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted RR, 7.74 (95% CI, 1.49-40.11)]. In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body [a mean quantity of 60 g/month (range, 12-170g)] over long periods of time.
Animal Data In an embryofetal development study in mice, subcutaneous administration of clobetasol propionate resulted in fetotoxicity at the highest dose tested ( 1mg/kg) and malformations at the lowest dose tested (0.03 mg/kg). Malformations seen included cleft palate and skeletal abnormalities. In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg.
Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.
8.2Lactation Risk Summary There is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. 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 clobetasol propionate could result in sufficient systemic absorption to produce detectable quantities in human milk.
The developmental and health benefits of breastfeeding should be considered along with the other’s clinical need for IMPOYZ Cream and any potential adverse effects on the breastfed infant from IMPOYZ Cream or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use IMPOYZ Cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply IMPOYZ Cream directly to the nipple and areola to avoid direct infant exposure.
8.4Pediatric Use The safety and effectiveness of IMPOYZ Cream in patients younger than 18 years of age have not been established; therefore, use in children younger than 18 years is not recommended. Because of a hig…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on IMPOYZ Cream in pregnant women to inform a drug-associated risk for adverse development outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroids during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use IMPOYZ Cream on the smallest area of skin and for the shortest duration possible (see Data ).
In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparisons of animal exposure with human exposure are provided due to minimal systemic exposure noted after topical administration of IMPOYZ Cream [see Clinical Pharmacology (12.3) ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk or birth defect loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality.
However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted RR, 7.74 (95% CI, 1.49-40.11)]. In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body [a mean quantity of 60 g/month (range, 12-170g)] over long periods of time.
Animal Data In an embryofetal development study in mice, subcutaneous administration of clobetasol propionate resulted in fetotoxicity at the highest dose tested ( 1mg/kg) and malformations at the lowest dose tested (0.03 mg/kg). Malformations seen included cleft palate and skeletal abnormalities. In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg.
Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of IMPOYZ Cream in patients younger than 18 years of age have not been established; therefore, use in children younger than 18 years 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 systemic toxicity, including HPA axis suppression when treated with topical drugs [see Warnings and Precautions (5.1) ]. Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.
Local adverse reactions including striae and skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. Avoid use of IMPOYZ Cream in the treatment of diaper dermatitis.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of IMPOYZ Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with topical corticosteroids has not identified differences in responses between the elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid responsive dermatoses is unknown. The contribution to efficacy by individual components of the vehicle has not been established.
12.2Pharmacodynamics Vasoconstrictor Assay IMPOYZ Cream, 0.025% is in the high range of potency as demonstrated in vasoconstrictor studies in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: HPA axis suppression was evaluated in a clinical trial in adult subjects (N=24) with moderate to severe plaque psoriasis involving a mean BSA of 26.5 +8.6%.
Treatment consisted of twice daily application of IMPOYZ Cream, 0.025% for 15 days. Adrenal suppression, as indicated by a 30-minute post-stimulation cortisol level ≤18 mcg/dL, was observed in 3 out of 24 subjects (12.5%) after 15 days.
12.3Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption.
Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile. In a pharmacokinetic study in 24 adult male and female subjects with moderate to severe psoriasis were treated twice daily for 15 days with a mean dose of approximately 3.7 g of IMPOYZ Cream, 0.025% per application to a mean BSA of 26.5 ± 8.6%.
On day 15, the mean + SD pre-treatment and post-treatment systemic concentrations of clobetasol propionate were 50.7 ± 96.0 pg/mL and 56.3 ± 104.7 pg/mL, respectively.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid responsive dermatoses is unknown. The contribution to efficacy by individual components of the vehicle has not been established.
16.1How Supplied IMPOYZ Cream, 0.025% is a white off-white cream, supplied as follows: 100 g aluminum tube NDC 68040-713-38
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied IMPOYZ Cream, 0.025% is a white off-white cream, supplied as follows: 100 g aluminum tube NDC 68040-713-38
16.2Storage Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Do not freeze.
📦 Storage and Handling ▾
16.2Storage Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Do not freeze.
📋 Description ▾
11 DESCRIPTION IMPOYZ (clobetasol propionate) Cream, 0.025% for topical use contains clobetasol propionate, a synthetic and fluorinated corticosteroid. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β-hydroxy-16 β-methyl-3,20-dioxopregna-1,4-dien-17-yl propanoate, and it has the following structural formula. Clobetasol propionate has a molecular formula of C 25 H 32 CIFO 5 and a molecular weight of 467.
It is a white to cream-colored crystalline powder practically insoluble in water. Each gram of IMPOYZ Cream contains 0.25 mg clobetasol propionate. It is an oil-in-water emulsion intended for topical application and contains the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, cyclomethicone, diethylene glycol monoethyl ether, glyceryl stearate and PEG 100 stearate, isopropyl myristate, methyl paraben, propyl paraben. purified water and white wax.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ) Pregnancy Advise pregnant women of the potential risk to a fetus and to use IMPOYZ Cream on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1) ] . Lactation Advise a woman to use IMPOYZ cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply IMPOYZ Cream directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2) ] .
Important Administration Instructions Instruct patients to discontinue IMPOYZ Cream when psoriasis is controlled. IMPOYZ Cream should not be used for longer than 2 weeks. Advise patients to contact the physician if no improvement is seen within 2 weeks.
Inform patients that total dosage should not exceed 50 grams per week [see Dosage and Administration (2) ]. Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s) unless directed by physician. Advise patients to avoid use on the face, scalp, groin, or axillae [see Dosage and Administration (2) ].
Inform patients that IMPOYZ Cream is for external use only. Advise patients that IMPOYZ Cream is not for ophthalmic, oral or intravaginal use. Patients should wash their hands after applying the medication [see Dosage and Administration (2) ] .
Do not use other corticosteroid-containing products while using IMPOYZ Cream. Effects on Endocrine System IMPOYZ Cream may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including IMPOYZ Cream, may require periodic evaluation for HPA axis suppression.
Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids. Patients should inform their physician(s) that they are using IMPOYZ Cream if surgery is contemplated [see Warnings and Precautions (5.1) ] .
Local Adverse Reactions Informed patients that topical corticosteroids may cause local adverse reactions, some of which may be irreversible. These reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids, including IMPOYZ Cream [see Warnings and Precautions (5.2) ] . Patients should report any sign of local or systemic adverse reactions to their physician.
Manufactured by DPT Laboratories Ltd. San Antonio, TX 78215 For Primus Pharmaceuticals, Inc., Scottsdale AZ 85253 IMPOYZ is a registered trademark of Primus Pharmaceuticals, Inc. www.primusrx.com Revised: 04/2021