SelRex75 ml

SelRex is a topical (scalp/skin) combination product indicated for the following conditions, most commonly formulated as a medicated shampoo or cleanser:

• Established/OTC-monograph use: Treatment of dandruff (pityriasis capitis) and relief of the itching, flaking, and scaling associated with dandruff.
• Established/OTC-monograph use: Seborrheic dermatitis of the scalp.
• Adjunct use: Symptomatic relief of scaling associated with mild scalp psoriasis, used as an adjunct to (not a replacement for) physician-directed psoriasis therapy.

SelRex is not intended for treatment of fungal infections of the skin other than dandruff/seborrheic dermatitis, nor for moderate-to-severe psoriasis, which require physician-directed treatment.

Salicylic Acid+Zinc Pyrithione is a fixed combination of two topical active ingredients:

• Salicylic Acid — a keratolytic (skin/scale-softening) agent that loosens and helps shed excess scalp scale.
• Zinc Pyrithione — an agent with antifungal and antibacterial activity that reduces Malassezia (formerly Pityrosporum) yeast overgrowth on the scalp, a factor implicated in dandruff and seborrheic dermatitis.

It is available as a medicated shampoo/topical cleanser for external use on the scalp and skin.

SelRex is an over-the-counter combination antidandruff and antiseborrheic topical product. It combines the keratolytic action of salicylic acid, which helps soften and remove excess flaking scalp scale, with the antifungal/antibacterial action of zinc pyrithione, which reduces the yeast organisms associated with dandruff and seborrheic dermatitis.

SelRex is typically formulated as a medicated shampoo intended for regular, topical use on the scalp and is not for internal or ophthalmic use.

SelRex belongs to the class of topical antidandruff / antiseborrheic agents, combining a keratolytic (salicylic acid) with a topical antifungal/antimicrobial agent (zinc pyrithione).

Salicylic Acid+Zinc Pyrithione acts through the complementary mechanisms of its two components:

• Salicylic acid is a keratolytic agent. It lowers the pH of the stratum corneum and promotes desquamation (shedding) of corneocytes by dissolving intercellular cement, which softens and loosens thickened, scaly skin and scalp debris, allowing it to be washed away more easily.
• Zinc pyrithione has antifungal and antibacterial properties. It inhibits growth of Malassezia species yeast on the scalp — organisms implicated in the pathogenesis of dandruff and seborrheic dermatitis — and also has some anti-inflammatory-like effect on scalp scaling, reducing flaking and associated itching.

Together, Salicylic Acid+Zinc Pyrithione reduces both the underlying microbial contributor and the visible scaling/flaking of dandruff and seborrheic dermatitis. Systemic absorption through intact skin is minimal with normal topical/shampoo use.

SelRex is for topical (external) scalp/skin use only, as a medicated shampoo/cleanser. It must not be swallowed, injected, or applied near the eyes or on mucous membranes. Rinse hands after use if not the treated area.

Clinically significant drug interactions with SelRex are not well established, given its topical route and minimal systemic absorption. However, the following should be noted:

• Concurrent use with other topical keratolytic, exfoliating, or medicated scalp/skin products (e.g., other salicylic acid, sulfur, coal tar, or retinoid-containing products) applied to the same area may increase local skin/scalp irritation, dryness, or peeling.
• There is no established clinically significant interaction between SelRex and systemically administered medications when used as directed topically.

Inform a physician or pharmacist of all other topical scalp or skin products in use before starting SelRex.

SelRex is generally well tolerated when used as directed. Reported adverse effects are usually local and mild:

• Common: scalp irritation, dryness, stinging, or burning sensation; mild itching; changes in hair/scalp oiliness.
• Less common: redness of the scalp or skin, mild hair texture changes, contact dermatitis.
• Rare: allergic (hypersensitivity) reactions such as rash, swelling, or significant itching beyond the treated area.

If severe irritation, signs of an allergic reaction, or worsening of scalp condition occur, discontinue SelRex and consult a physician.

There are no well-controlled studies specifically establishing the safety of SelRex in human pregnancy or lactation. Because SelRex is applied topically to the scalp and systemic absorption is minimal when used as directed, the risk to a fetus or breastfed infant is generally considered low; however, as with any medicated product, SelRex should be used during pregnancy and breastfeeding only if clearly needed and after consulting a physician, who can weigh the potential benefit against any potential risk. Avoid applying to large areas of broken or inflamed skin during pregnancy or lactation without medical advice.

The following precautions apply to the use of SelRex:

• For external use only; avoid contact with the eyes, lips, and mucous membranes. If accidental contact with the eyes occurs, rinse thoroughly with water.
• Do not use on broken, raw, or actively inflamed/infected skin unless directed by a physician.
• Discontinue use and consult a physician if scalp irritation, excessive dryness, burning, or a rash develops, or if the condition worsens.
• If there is no improvement within the period stated on the product label (commonly 2-4 weeks), stop use and seek medical advice, as the diagnosis may need to be reassessed.
• Keep out of reach of children; not intended for oral or ophthalmic use.
• Use with caution in patients with widespread or extensive dermatitis, given the potential (though limited with topical salicylic acid) for increased systemic absorption over very large or compromised skin areas.

SelRex is intended for external topical use only. Accidental ingestion or significant overuse may cause gastrointestinal upset, or, in the case of large accidental ingestion of salicylic-acid-containing product, symptoms of salicylate toxicity (e.g., nausea, vomiting, ringing in the ears, rapid breathing, confusion). Excessive or prolonged topical use may cause significant local skin/scalp irritation.

If accidental ingestion occurs, or if signs of toxicity or a severe skin reaction develop, seek immediate medical attention or contact a poison control center/emergency services right away. Do not attempt to manage a suspected overdose or ingestion at home without professional guidance.

Store at room temperature (below 30°C), away from light and moisture. Keep the container tightly closed and out of reach of children.

Pediatric use: Use of SelRex in children under 2 years of age should only be under the direction of a physician, as safety and efficacy in this age group are not well established. In older children, use only as directed on the product label or by a physician/pharmacist.

Elderly: No specific dose adjustment is generally required for elderly patients using SelRex topically; the same precautions regarding skin irritation and eye contact apply.

Renal/hepatic impairment: Given minimal systemic absorption with normal topical use, no specific dose adjustment is established for renal or hepatic impairment; however, patients with extensive skin disease should use with caution (see Precautions and Warnings).

Pregnancy and lactation: See Pregnancy and Lactation section.

SelRex is typically used 2-3 times weekly during the initial treatment phase until dandruff/seborrheic dermatitis symptoms improve, generally within 2-4 weeks. Thereafter, frequency may be reduced (e.g., to once weekly or as needed) for maintenance and prevention of recurrence. If there is no improvement within the timeframe stated on the product label, or if symptoms persist beyond several weeks, discontinue and consult a physician to reassess the diagnosis and treatment plan.

Topical antidandruff agent; keratolytic (salicylic acid); topical antifungal/antimicrobial agent (zinc pyrithione)

Salicylic Acid+Zinc Pyrithione combines two complementary mechanisms: salicylic acid acts as a keratolytic, loosening and promoting shedding of excess scalp scale by softening the intercellular matrix of the stratum corneum, while zinc pyrithione exerts antifungal and antibacterial activity that suppresses Malassezia yeast overgrowth on the scalp, a key contributor to dandruff and seborrheic dermatitis. Together these actions reduce flaking, scaling, and associated itching.

Use of SelRex in children under 2 years of age should only be done under the direction and supervision of a physician, as safety and efficacy have not been well established in this age group. For children 2 years and older, SelRex may be used as directed on the product label or as advised by a physician or pharmacist, following the same precautions regarding eye contact, broken skin, and discontinuation if irritation occurs. Keep out of reach of children at all times, and supervise use to prevent accidental ingestion.