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Brand Name :
Tri-Luma
Synonyms :
tretinoin/ hydroquinone/ fluocinolone
Class :
Corticosteroids, Depigmenting Agents, Topical
Dosage Forms & Strengths
Cream
(0.01%/0.05%/4%)/30g
{fluocinolone (0.01%)/tretinoin (0.05%)/hydroquinone (4%)/30g}
Safety and efficacy not determined
Refer to adult dosing
Actions and Spectrum:
It is a corticosteroid that lessens skin irritation, inflammation, and redness.
It is a retinoid that encourages skin cell renewal, which lessens the visibility of dark patches and discolouration.
It is a skin-lightening substance that prevents the synthesis of melanin, the pigment that gives skin its colour.
This medication’s primary focus is on treating skin hyperpigmentation, which can be brought on by a variety of things including ageing, hormonal changes, and UV exposure.
By lowering inflammation, accelerating skin cell turnover, and suppressing melanin formation, the combination of these three active substances reduces dark spots and discolouration.
Frequency defined
1-10%
Hyperesthesia (2%)
Rosacea (1%)
Xerostomia (1%)
Acne (5%)
Paraesthesia (3%)
Vesicles (1%)
Telangiectasia (3%)
<1%
Miliaria
Skin atrophy
Itching
Ochronosis
HPA axis suppression
Hypopigmentation
Perioral dermatitis
Acneiform
Eruptions
>10%
Burning (16-20%)
Dryness (11-15%)
Pruritis (11-15%)
Erythema (41-45%)
Desquamation (36-40%)
Black Box Warning
According to this medication’s black box warning, prolonged usage or high dosages of this drug are more likely to result in skin cancer.
The caution also advises patients should limit sun exposure, use protective clothes and sunscreen when out in the sun, and not take the drug for more than 8 weeks.
Contraindication/Caution:
Contraindication:
Caution:
Pregnancy warnings:
Pregnancy category: C
Lactation: Excretion into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology
For fluocinolone
It is a synthetic corticosteroid that suppresses the immune system while lowering inflammation. Vasoconstriction, antipruritic, and anti-inflammatory effects are all present.
For tretinoin
It is a retinoid that functions by accelerating cell renewal while reducing melanin synthesis.
For hydroquinone
It is a skin lightening medication that works by preventing the tyrosinase enzyme, which is essential for melanin synthesis.
Pharmacodynamics
For fluocinolone
It controls protein synthesis and gene expression by acting on glucocorticoid receptors, which reduces the generation of inflammatory cytokines and other inflammatory mediators. As a result, the redness, swelling, and itching brought on by skin inflammation are lessened.
For tretinoin
It is a retinoid that functions by attaching to certain receptors on skin cells and altering gene expression, which increases cell turnover and causes dead skin cells to exfoliate. This lessens hyperpigmentation and improves the texture and tone of the skin.
For hydroquinone
It is a skin lightening medication that works by preventing the tyrosinase enzyme, which is essential for melanin synthesis. This reduces skin pigmentation and gives the skin a more equal tone.
Pharmacokinetics
Absorption
The afflicted region of the skin is treated topically with the drug.
Through skin absorption, fluocinolone reaches the circulation.
Through skin absorption, retinol gets into the bloodstream.
Through skin absorption, hydroquinone enters the circulation.
Distribution
fluocinolone is widely distributed in the body and has a strong protein binding capacity.
The liver is where tretinoin is metabolised and is transported throughout the body.
The liver is where the body’s hydroquinone is processed after being disseminated throughout.
Metabolism
The liver breaks down fluocinolone, which is then eliminated in the urine.
tretinoin is eliminated in the urine and feces after being processed in the liver.
The liver converts hydroquinone, which is then eliminated through the urine and feces.
Elimination and excretion
Urine contains the excretion of fluocinolone.
Both urine and feces include tretinoin’s excretion.
Both urine and feces include hydroquinone’s excretion.
Administration:
To treat hyperpigmentation and dark patches on the skin, a combination of drug fluocinolone, tretinoin and hydroquinone is used topically.
Patient information leaflet
Generic Name: fluocinolone/tretinoin/hydroquinone
Why do we use fluocinolone/tretinoin/hydroquinone?
fluocinolone, tretinoin and hydroquinone are three drugs that are used topically to treat melasma, a particular kind of hyperpigmentation that is characterised by dark spots on the face.
Together, the active substances diminish hyperpigmentation and enhance the skin’s general look.
Other forms of skin discoloration, such dark patches or post-inflammatory hyperpigmentation brought on by acne, may also be treated with the drug.