BENZAC AC 5% GEL 60G

Indications

Approved Uses

Acne vulgaris (mild to moderate).

Dosage & Administration

Dosing by Condition

Acne vulgaris: apply a thin layer to affected area(s) once daily initially; may increase to twice daily as tolerated; consider lower strength (e.g., 2.5%) for sensitive skin, but this product is 5%.

Initial Dose

Apply a thin layer to affected area once daily for the first 1-2 weeks

Maintenance Dose

Apply a thin layer to the affected area once or twice daily as tolerated. [18, 26]

Maximum Dose

Apply a thin layer once or twice daily as tolerated; do not exceed twice daily

Dose Adjustment Notes

If excessive dryness/irritation occurs, reduce frequency to once daily or every other day and/or use a moisturizer; no systemic dose adjustment is needed due to minimal systemic absorption with topical use.

How to Take

Cleanse the skin and pat dry; apply a thin film of BENZAC AC 5% gel to the affected area(s) once daily initially, then increase to twice daily if tolerated; avoid eyes, lips, and mucous membranes and broken/irritated skin; wash hands after application; allow to dry and be aware it can bleach hair/fabrics.

Side Effects

Common Side Effects

Local irritation: dryness, peeling/scaling, erythema, burning/stinging, itching; contact dermatitis; and bleaching/discoloration of hair and colored fabrics.

Side Effect Frequency

Very common: dryness, peeling, erythema/irritation; Common: burning, stinging, pruritus; Rare: allergic contact dermatitis and swelling/edema (including facial swelling).

Safety & Warnings

Contraindications

Hypersensitivity to benzoyl peroxide or any excipients

Warnings & Precautions

For external use only; avoid eyes/lips/mouth/mucosa; do not apply to broken/sunburned skin; may cause irritation-start once daily and reduce/stop if severe; may increase photosensitivity-use sunscreen/limit sun; may bleach hair and colored fabrics

Driving Warning

Safe

Drug Interactions

Drug Interactions

Avoid/limit concurrent use with other irritating topical acne agents (e.g., retinoids, salicylic acid, AHAs) due to additive irritation; with topical dapsone/sulfone products may cause temporary yellow/orange discoloration of skin/hair; may bleach hair/fabrics

Interaction Severity

MODERATE: concomitant topical retinoids/other irritants (additive irritation; separate application times if used together). MODERATE: topical dapsone (may cause temporary yellow/orange/brown discoloration of skin/facial hair).

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Stopping the Medicine

Can be stopped at any time; discontinue if severe irritation or allergic reaction occurs

Overdose

Excessive topical use may cause marked erythema, dryness, peeling, burning, or swelling-stop use, rinse off, and provide symptomatic care (e.g., emollient/cool compress); accidental ingestion is expected to cause GI irritation-seek medical advice/poison center

Patient Counseling

Apply a thin layer to clean, dry skin (start once daily or every other day, then increase to 1-2 times daily as tolerated); avoid eyes, lips, and mucous membranes and do not apply to broken/sunburned/eczema-affected skin; expect dryness, peeling, redness, and stinging early-use a non-comedogenic moisturizer and reduce frequency if irritating; benzoyl peroxide can bleach hair and colored fabrics-wash hands after use and let it dry before contact with towels/clothing; use daily sunscreen and limit excessive sun/UV exposure; stop and seek medical advice if severe irritation, swelling, blistering, or signs of allergy occur.

Monitoring Requirements

No routine monitoring; monitor for signs of contact dermatitis or allergic reaction

Pharmacology

Mechanism of Action

Releases reactive oxygen species that oxidize bacterial proteins (reducing Cutibacterium acnes) and has mild keratolytic/comedolytic effects that promote desquamation and help prevent follicular plugging.

Duration of Effect

Requires ongoing/continuous use to maintain acne control; clinical benefit is maintained only with continued application and acne may recur after stopping.

Half-Life

Not well established/clinically not meaningful for topical benzoyl peroxide; systemic benzoic acid is cleared rapidly (on the order of hours).

Bioavailability

Minimal systemic absorption; approximately 5% of the dose is absorbed through the skin as benzoic acid.

Metabolism

Metabolized in the skin to benzoic acid; any absorbed benzoic acid is further conjugated systemically (e.g., to hippuric acid) before renal excretion.

Excretion

Systemically absorbed benzoyl peroxide is converted to benzoic acid and excreted in urine primarily as hippuric acid (and other benzoate conjugates).

Product Information

Available Dosage Forms

For this SFDA-registered product: Gel (topical) in a tube (60 g).

Composition per Dose

Each gram of gel: 50 mg benzoyl peroxide (5% w/w) in an aqueous gel base

Generic Availability

Yes

Skin Condition

Acne

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