Match the route, vehicle and treatment limit.
Most selected skin products have a 2-week limit; some have narrowly defined 4-week regimens. Systemic absorption can suppress adrenal function. Only the sterile Byqlovi ophthalmic product belongs in the eye; its eye-pressure and infection precautions require ophthalmic follow-up.
Warnings and precautionsIndications
Vehicle, site, age and diagnosis determine labeled use.
Skin and scalp indications
Selected 0.05% cream, gel and ointment relieve inflammation and itching of steroid-responsive dermatoses; use below age 12 is not recommended and pediatric effectiveness is not established. Scalp solution treats moderate-to-severe steroid-responsive scalp dermatoses; use below 12 is not recommended. Standard foam is labeled for moderate-to-severe scalp plaque psoriasis and mild-to-moderate non-scalp plaque psoriasis, excluding face and intertriginous areas, at ≥12. Emulsion foam treats steroid-responsive dermatoses at ≥12.
Adult-only selected skin products
Shampoo: moderate-to-severe scalp psoriasis at ≥18. Spray: moderate-to-severe plaque psoriasis affecting up to 20% body surface area at ≥18. Lotion: steroid-responsive dermatoses at ≥18, with a limited psoriasis extension. Impoyz 0.025% cream: moderate-to-severe plaque psoriasis at ≥18. Avoid assuming a lower concentration means a pediatric or longer-duration indication.
Ophthalmic indication and scope
Byqlovi sterile ophthalmic suspension is indicated for inflammation and pain following ocular surgery. Pediatric safety and effectiveness are unestablished. Dermal products are not ophthalmic medicines. This profile does not supply an off-label chronic skin, genital, scalp or eye maintenance protocol.
Dosage and administration
Use a thin amount for the shortest product-specific course.
Cream, gel, ointment and scalp solution
Selected 0.05% cream, gel and ointment: thin layer twice daily, gently rub in; maximum 2 consecutive weeks and 50 g/week. Scalp solution: affected scalp twice daily, maximum 2 weeks and 50 mL/week. Neither selected label permits occlusive dressings.
Foam, lotion, spray and Impoyz regimens
Do not apply a blanket 4-week allowance to all skin products. Standard foam: invert the can and dispense into its cap or affected skin, not warm hands unless hands are the treatment site. Emulsion foam: shake, invert and dispense a small amount, then massage in. Wash hands after use.
| Product | Selected regimen and limits |
|---|---|
| Standard or emulsion foam 0.05% | Twice daily for up to 2 weeks; maximum 50 g or 21 capfuls/week. |
| Lotion 0.05% | Twice daily; maximum 50 g (50 mL)/week, normally 2 weeks. Selected localized plaque lesions <10% BSA inadequately improved may receive 2 more weeks after benefit-risk assessment. |
| Spray 0.05% | Twice daily; maximum 50 g (59 mL)/week, 26 sprays/application and 52/day. Beyond 2 weeks only localized inadequately improved plaque lesions, with reassessment; never beyond 4 weeks. |
| Impoyz cream 0.025% | Twice daily; up to 2 weeks and maximum 50 g/week. Avoid scalp as well as face, axillae, groin and intertriginous sites. |
Shampoo administration
For adults: once daily on DRY affected scalp, leave 15 minutes, then add water, lather and rinse scalp and any contacted skin thoroughly. Maximum 4 consecutive weeks and 50 g (50 mL)/week. Avoid eyes and lips. Stop when controlled; if no improvement by 4 weeks, reassess. Do not use a shower cap or other occlusion unless specifically directed.
Byqlovi postoperative eye regimen
Instill one drop in the affected eye twice daily starting the day after surgery, throughout the first 2 postoperative weeks. Wash hands; separate other eye drops by at least 5 minutes. Remove contact lenses before instillation and wait 15 minutes before reinsertion. Keep the dropper tip from touching any surface.
Organ impairment and systemic exposure
The selected labels do not provide a renal or hepatic dose formula. For dermal therapy, liver failure can increase HPA-suppression risk; large areas, impaired barrier, prolonged treatment, occlusion and combined corticosteroids also increase systemic exposure. Do not extend a course or escalate quantity solely because absorption appears low.
Safety
Local tissue effects and systemic steroid toxicity remain possible.
Warnings and precautions
- Skin products can suppress the HPA axis and cause adrenal insufficiency during treatment or after withdrawal, Cushing syndrome, hyperglycemia or glucosuria. Risk rises with high potency, large areas, prolonged courses, occlusion, damaged skin, liver failure and young age. Confirmed suppression may require supervised gradual withdrawal, lower frequency or a weaker steroid; severe insufficiency may need systemic steroid support.
- Skin atrophy, striae and telangiectasia can be irreversible. Avoid face, groin, axillae and prohibited sites; Impoyz also excludes scalp. Avoid rosacea and perioral dermatitis. Do not use skin formulations in the eye, mouth or vagina, and do not occlude unless the selected label and clinician permit it.
- Treat concurrent skin infection with an appropriate antimicrobial; discontinue clobetasol if response is not prompt until infection is controlled. Failure to heal may indicate allergic contact dermatitis; reassess and consider patch testing.
- Dermal corticosteroids can increase glaucoma or cataract risk; report visual symptoms. Byqlovi can raise eye pressure, promote cataracts, delay healing and cause perforation in thinned cornea or sclera. Monitor IOP if used ≥10 days; initial prescriptions and renewals require appropriate ophthalmic examination.
- Byqlovi can mask or worsen ocular infection. Reassess if symptoms do not improve after 2 days; persistent corneal ulceration requires fungal consideration. Prior ocular herpes requires great caution. Avoid dropper contamination and instillation over contact lenses.
- Standard and emulsion foams, spray and scalp solution require fire precautions. Foams are pressurized: avoid fire, flame and smoking during and immediately after application; do not puncture or incinerate cans.
Contraindications
Selected cream, gel and ointment: hypersensitivity to ingredients. Selected scalp solution: primary scalp infections or hypersensitivity to clobetasol, other corticosteroids or ingredients. The selected foams, shampoo, spray, lotion and Impoyz labels list no formal contraindications; their route, age, site and safety restrictions still apply. Byqlovi is contraindicated in most active viral corneal/conjunctival diseases, including epithelial herpes simplex keratitis, vaccinia and varicella, and ocular mycobacterial or fungal disease.
Boxed warning status
None of the selected current U.S. labels has a boxed warning. This does not remove adrenal, local tissue or ophthalmic risks.
Adverse reactions and excess exposure
Skin products may cause burning, stinging, itching, irritation, dryness, folliculitis, acneiform changes, discoloration, atrophy or secondary infection; reactions vary by vehicle. Byqlovi trials reported ocular inflammation, corneal edema, anterior chamber inflammation, cystoid macular edema, IOP elevation, photophobia and vitreous detachment; some events may reflect surgery. Excess dermal use can produce systemic steroid effects and requires medical assessment; do not abruptly change prolonged excessive exposure without advice. Seek Poison Help or urgent care for accidental ingestion or serious symptoms.
Drug interactions
Concurrent steroid exposure and application practices alter risk.
Relevant co-treatment considerations
Selected labels do not establish a comprehensive systemic CYP interaction regimen. Multiple corticosteroid products can increase total systemic exposure and adrenal risk; review prescription, inhaled, nasal, injected and nonprescription steroids together. Occlusive coverings and inappropriate prolonged application increase absorption. For Byqlovi, separate other eye drops by at least 5 minutes and review eye treatments with the ophthalmic prescriber.
Use in specific populations
Age eligibility differs by vehicle; minimize pregnancy and infant exposure.
Pregnancy and lactation
Human data do not establish absence of risk. Selected dermal labels note animal developmental toxicity; some report observational low-birthweight associations with large cumulative potent-steroid exposure. Use the smallest appropriate skin area for the shortest duration. Milk exposure and infant effects are uncertain; do not apply products to nipple or areola where direct infant exposure can occur. Byqlovi systemic levels after ocular dosing are minimal, but pregnancy data are inadequate and milk data absent; weigh benefit and risk rather than declaring it risk-free.
Pediatric and geriatric considerations
Standard and emulsion foams are labeled at ≥12; selected cream, gel, ointment and scalp solution do not recommend use below 12, and cream, gel and ointment pediatric effectiveness remains unestablished. Shampoo, spray, lotion and Impoyz are adult products at ≥18; Byqlovi pediatric safety/effectiveness are unestablished. Children have greater systemic absorption relative to body mass and may develop adrenal suppression, growth effects or intracranial hypertension. Avoid diaper-area use. Older dermal-product data are limited; use cautiously. Byqlovi studies found no overall difference at ≥65.
Renal and hepatic impairment
No validated product-specific renal/hepatic adjustment algorithm is given. Liver failure is a dermal adrenal-suppression risk factor; reduce avoidable exposure and assess clinically indicated HPA testing. Low ophthalmic exposure does not justify exceeding the labeled eye regimen.
Clinical pharmacology
Clobetasol has anti-inflammatory and vasoconstrictive steroid effects.
Mechanism and potency
The precise anti-inflammatory mechanism is not fully established. Corticosteroids alter cellular signaling and inflammatory mediator pathways. Selected 0.05% skin products are super-high potency; Impoyz 0.025% is in the high potency range in vasoconstrictor studies. Similar skin-blanching scores do not establish therapeutic equivalence between vehicles or concentrations.
Pharmacokinetics and exposure
Absorption through intact skin is possible and rises with vehicle differences, inflammation, barrier damage and occlusion. Absorbed corticosteroids are primarily hepatically metabolized and renally eliminated, with some biliary excretion; a universal topical half-life is not established. In the Byqlovi healthy-adult study, plasma peaks were below quantitation in many profiles; measurable peaks occurred at about 0.5–1 hour and fell below quantitation by 4–5 hours. Skin and eye exposure studies do not establish interchangeable dosing.
Monitoring and counseling
Track response, course length, quantity and local or systemic toxicity.
Monitoring parameters
- Record treated site, body surface area, weekly amount and duration; reassess if not improving within the selected product’s interval.
- Inspect for skin thinning, striae, irritation, contact allergy or infection; review glycemic changes and systemic steroid symptoms.
- Assess HPA suppression in higher-risk exposure; ACTH stimulation testing and, in selected older labels, morning cortisol or urinary free cortisol are described. Confirmed suppression needs clinician-directed exposure reduction and possible adrenal support.
- For Byqlovi, ophthalmic examination guides prescribing and renewal; check IOP at ≥10 days and reassess nonimprovement after 2 days.
- Review combined steroid products, growth concerns in children and visual complaints.
Patient counseling information
- Use only the prescribed vehicle, route, site and course; stop when controlled and do not share or reuse for an undiagnosed rash. Wash hands after dermal application.
- Do not cover treated skin without approval. Avoid prohibited facial, groin, axillary and diaper areas. Skin products are not eye drops.
- Apply shampoo to dry scalp for 15 minutes before rinsing. Use the foam’s own dispensing instructions; pressurized and flammable products require fire precautions.
- For Byqlovi, avoid touching the tip, separate drops by 5 minutes, remove lenses and wait 15 minutes before reinsertion. Report worsening eye pain, vision change or failure to improve.
- Report unusual weakness or systemic steroid symptoms after excessive or prolonged use; arrange supervised management rather than an arbitrary self-taper.
Product identification
Concentration alone does not identify the correct preparation.
Representative dermal product · Sun cream 0.05%
- Form and strength
- Dermal cream · 0.05% (0.5 mg/g)
- Distributor
- Sun Pharmaceutical Industries, Inc.
- Representative package
- 30 g tamper-evident tube
- Example NDC
- 51672-1258-2
Dosage forms and strengths
Selected dermal 0.05% forms: cream, gel, ointment, scalp solution, standard foam, emulsion foam, shampoo, spray and lotion. Impoyz dermal cream is 0.025%. Byqlovi is sterile ophthalmic suspension 0.05% (0.5 mg/mL), 3.5 mL in a 5 mL bottle, NDC 82667-021-05. The same percentage across routes does not make products interchangeable.
Storage and handling
Selected skin products generally store at 20–25°C; follow each package’s excursions. Sun cream, gel and ointment: do not refrigerate. Scalp solution: tight container, do not refrigerate, avoid open flame. Lotion and Impoyz: do not freeze. Spray: do not freeze, refrigerate or exceed 30°C. Foams: do not puncture/incinerate or expose above 49°C. Byqlovi: upright at 15–25°C, do not freeze; close with its pink cap, do not use a broken tamper ring, and after opening use only until the bottle expiration date.
References
Original sources for the clinical and product information.
- DailyMed / National Library of MedicineSun clobetasol 0.05% cream, gel and ointment
Full public manufacturer label and patient instructions; SPL version 11, effective 20260323. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineEncube clobetasol 0.05% scalp solution
Full public manufacturer label and patient instructions; SPL version 3, effective 20260421. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineSun clobetasol 0.05% foam
Full public manufacturer label and patient instructions; SPL version 4, effective 20260714. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicinePadagis clobetasol 0.05% emulsion foam
Full public manufacturer label and patient instructions; SPL version 8, effective 20220331. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicinePadagis clobetasol 0.05% shampoo
Full public manufacturer label and patient instructions; SPL version 14, effective 20251130. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineAlembic clobetasol 0.05% spray
Full public manufacturer label and patient instructions; SPL version 9, effective 20260717. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineSun clobetasol 0.05% lotion
Full public manufacturer label and patient instructions; SPL version 8, effective 20250707. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineImpoyz clobetasol 0.025% cream
Full public manufacturer label and patient instructions; SPL version 3, effective 20240130. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineByqlovi clobetasol 0.05% ophthalmic suspension
Full public manufacturer label and patient instructions; SPL version 3, effective 20260126. Product-specific directions reviewed October 1, 2026.