Fluocinolone + hydroquinone + tretinoin cream
کرم سهگانه ملاسما (فلوسینولون + هیدروکینون + ترتینوئین)
🧴 DermatologicalsDepigmenting combination
Market / country: 🇺🇸 USA
Tri-Luma (US)
🧮 Dose calculator
Melasma · Regimen source: FDA Tri-Luma · 2FDA Tri-Luma · 1
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to any component. FDA Tri-Luma · 4
Warnings
- • Contains sulfite (allergic reactions and asthma attacks in susceptible people). FDA Tri-Luma · 5
Formulations
- Fluocinolone 0.01% / hydroquinone 4% / tretinoin 0.05% cream — cream 🇺🇸 USA FDA Tri-Luma · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Tri-Luma · 8.1
“Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Tri-Luma · 8.3
“Because many drugs are secreted in human milk, caution should be exercised when TRI-LUMA Cream is administered to a nursing woman.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Tri-Luma · 8.4
“Safety and effectiveness of TRI-LUMA Cream in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Tri-Luma · 8.5
“In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA021112
- DailyMed (FDA label)FDA Tri-Luma
- MedlinePlus (NIH)Fluocinolone Topical
- WHO ATC/DDD❌ None
- Darooyab (Iran)Fluocinolone
🇮🇷 Registered in Iran Darooyab · G-2101/Fluocinolone
Dosage forms with Iranian generic codes, per Darooyab.
- 00546 · FLUOCINOLONE ACETONIDE 0.025% 15G CREAM · کرم فلوئوسینولون استوناید ۰٫۰۲۵ درصد ۱۵ گرم
- 00545 · FLUOCINOLONE ACETONIDE 0.025% 15G OINT · پماد فلوئوسینولون استوناید ۰٫۰۲۵ درصد ۱۵ گرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Tri-Luma · 3FDA Tri-Luma · 2FDA Tri-Luma · 1FDA Tri-Luma · 4FDA Tri-Luma · 5FDA Tri-Luma · SPL approval / marketing categoryFDA Tri-Luma · 8.1FDA Tri-Luma · 8.3FDA Tri-Luma · 8.4FDA Tri-Luma · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-2101/Fluocinolone
- Clinical review⚠ Unverified