Rhubarb Extract + Salicylic Acid

• Approved Indications:
• Treatment of hyperkeratotic dermatologic conditions such as psoriasis (mild to moderate plaque type) and chronic eczema characterized by thickened, scaly skin.
• Keratolytic agent to soften and remove excessive keratin in disorders with hyperkeratosis.
• Clinically Accepted Off-Label Uses:
• Adjunctive treatment for acne vulgaris to promote exfoliation and unclog pores.
• Management of lichen planus and other inflammatory dermatoses with hyperkeratosis.
• Treatment of calluses and seborrheic keratosis for skin smoothing.

• Apply a thin layer of the topical formulation to the affected skin areas once or twice daily, depending on severity and physician advice.
• Duration generally ranges from 2 to 6 weeks, with assessment for continued benefit.
• Avoid application to broken skin, mucous membranes, or large body areas to minimize systemic absorption, especially of salicylic acid.
• Pediatric Use:
• Use cautiously; limited safety data, avoid extensive or prolonged application.
• Elderly and Special Populations:
• No dosage adjustment required but monitor for skin sensitivity.

Rhubarb Extract contains anthraquinones and tannins that exert anti-inflammatory, astringent, and antioxidant effects, reducing skin inflammation and modulating keratinocyte proliferation. Salicylic Acid acts as a keratolytic by disrupting intercellular bonds in the stratum corneum, promoting exfoliation of dead skin cells, reducing scaling, and enhancing skin renewal. Combined, these effects lead to reduction of hyperkeratosis and improved skin texture.

• Absorption: Minimal systemic absorption through intact skin; absorption increases with damaged or large-area application.
• Distribution: Negligible systemic distribution from topical use.
• Metabolism: Salicylic acid is metabolized hepatically to salicyluric acid and other conjugates. Rhubarb constituents have limited systemic metabolism.
• Elimination: Absorbed salicylic acid is primarily excreted renally; rhubarb components are minimally systemically available.

• Pregnancy: Topical use is generally considered low risk, but caution is advised due to limited controlled data. Avoid extensive or prolonged use during pregnancy.
• Lactation: Limited data; minimal systemic absorption suggests low risk, but avoid nipple area application during breastfeeding.

• Topical keratolytic and anti-inflammatory combination.

• Hypersensitivity to rhubarb extract, salicylic acid, or formulation excipients.
• Application on broken, ulcerated, or infected skin.
• Known allergy to aspirin or other salicylates.
• Use in infants under 2 years old is contraindicated due to risk of salicylate toxicity.

• Avoid application to large body surface areas or under occlusion to prevent systemic salicylate toxicity.
• Discontinue if significant irritation, rash, or allergic reactions occur.
• Use cautiously in patients with renal or hepatic impairment.
• Avoid contact with eyes, mucous membranes, and genitals.

• Common: Mild local irritation, redness, dryness, or peeling.
• Uncommon: Allergic contact dermatitis, photosensitivity reactions.
• Rare: Systemic salicylate toxicity symptoms (tinnitus, nausea) with overuse.

• Minimal systemic absorption limits interactions.
• Caution when used with systemic anticoagulants or other salicylate-containing products due to additive effects.

• No major recent changes in indications or safety warnings.
• Continued clinical support for keratolytic use in hyperkeratotic dermatoses.

• Store at 20°C to 25°C (68°F to 77°F) in a tightly closed container.
• Protect from light, moisture, and freezing.
• Keep out of reach of children.