ALFACORT CREAM 15G

Indications

Approved Uses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (e.g., eczema and dermatitis, including contact/atopic forms; insect bite reactions; and other mild inflammatory itchy skin conditions).

Dosage & Administration

Dosing by Condition

Apply a thin layer to affected areas 1-2 times daily (up to 3-4 times daily short-term if needed) and taper/stop when controlled; limit duration especially on face/flexures and in children, and seek medical advice if not improving within ~7 days.

Initial Dose

Apply a thin layer to the affected area 2-3 times daily.

Maximum Dose

Apply a thin layer 1-2 times daily; OTC self-treatment should not exceed 7 days unless advised by a clinician

Children's Dosage

Use with caution. Apply sparingly 1-2 times daily for the shortest possible duration. A course should not normally exceed 7 days. Not recommended for children under 2 years without medical advice.

Dose Adjustment Notes

Use the smallest effective amount for the shortest duration; avoid prolonged use on large areas and avoid occlusive dressings unless directed; reduce frequency/stop as symptoms improve.

How to Take

Clean (wash) and dry the affected area, then apply a thin layer of ALFACORT (hydrocortisone acetate 1%) cream and rub in gently; wash hands after use unless treating the hands; avoid contact with eyes/mouth and avoid applying to broken or infected skin unless advised by a clinician.

Side Effects

Common Side Effects

Application-site burning/stinging, itching, irritation/redness, and dryness; with prolonged or extensive use: skin thinning (atrophy), hypopigmentation, and folliculitis.

Side Effect Frequency

Common: application-site burning/stinging, itching, irritation, dryness/erythema. Uncommon: folliculitis, acneiform eruption, perioral dermatitis, contact dermatitis, hypopigmentation, hypertrichosis. Rare/with prolonged or extensive use (especially under occlusion or on thin skin): skin atrophy, striae, telangiectasia, secondary infection, and systemic effects such as HPA-axis suppression/Cushingoid features; ocular effects (e.g., blurred vision, glaucoma/cataract) are rare and mainly associated with periocular use or significant systemic absorption.

Safety & Warnings

Contraindications

Hypersensitivity to hydrocortisone acetate or excipients; untreated bacterial, fungal, or viral skin infections; rosacea; perioral dermatitis; acne vulgaris

Warnings & Precautions

External use only; avoid eyes/mucosa and avoid periocular use unless directed; do not use on untreated infections or broken skin; avoid occlusion unless directed; use sparingly on face/flexures/genitals and limit duration; stop and seek advice if irritation, worsening, or no improvement within 7 days

Age Restriction

Children <2 years: use only on a doctor’s advice/supervision

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant interactions expected with standard topical use; avoid concurrent use of other corticosteroid products on the same/large areas and use caution with strong CYP3A4 inhibitors if extensive/occlusive use (systemic absorption) occurs

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Use with caution. Apply sparingly 1-2 times daily for the shortest possible duration. A course should not normally exceed 7 days. Not recommended for children under 2 years without medical advice.

Elderly

Use with caution; elderly patients have thinner, more fragile skin with increased risk of atrophy and systemic absorption. Use the lowest effective amount for the shortest duration

Kidney Impairment

No dose adjustment needed (topical use)

Storage & Patient Advice

Missed Dose

Apply when remembered; if it is close to the next application, skip the missed dose and continue the regular schedule-do not apply extra to make up for it.

Stopping the Medicine

May stop when controlled after short courses; if used for prolonged periods, on large areas, or under occlusion, taper frequency to reduce rebound/flare risk

Overdose

Acute topical overdose is unlikely; chronic excessive use (large areas/occlusion/prolonged) can cause local atrophy/striae and systemic effects (HPA-axis suppression/Cushingoid features); if ingested, seek medical advice/poison center-manage supportively

Patient Counseling

Apply a thin layer only to affected skin; avoid eyes/mouth and wash hands after use; do not use on broken/infected skin or under occlusion unless advised; use the shortest duration and stop/taper when controlled; seek medical advice if worsening or not improved within ~7 days, and use extra caution/short courses on face/flexures and in children.

Monitoring Requirements

No routine monitoring for short-term OTC use; if prolonged use, large-area application, use on face/flexures, occlusion, or pediatric use: monitor for skin atrophy/striae/telangiectasia, secondary infection, and rare systemic effects (HPA-axis suppression).

Pharmacology

Mechanism of Action

Hydrocortisone acetate (a low-potency topical corticosteroid) binds intracellular glucocorticoid receptors to downregulate pro-inflammatory gene transcription and mediators (e.g., prostaglandins/leukotrienes), producing anti-inflammatory, antipruritic, and vasoconstrictive effects in skin.

Bioavailability

Percutaneous absorption is generally low for hydrocortisone acetate 1% cream when used as directed, but it is highly variable by body site and skin condition; absorption increases with thin skin (e.g., face/genitals), damaged/inflamed skin, large surface area use, prolonged use, and occlusion.

Metabolism

The absorbed fraction is metabolized primarily in the liver (and to some extent in peripheral tissues) via reduction and subsequent conjugation (glucuronide/sulfate) to inactive metabolites.

Protein Binding

For systemically absorbed hydrocortisone: high protein binding, typically >90% (mainly to corticosteroid-binding globulin/transcortin and albumin).

Product Information

Available Dosage Forms

Cream

Composition per Dose

Each gram of cream: 10 mg hydrocortisone acetate (equivalent to 1% w/w)

Generic Availability

Yes

OTC Alternatives

Other OTC low-potency topical corticosteroids such as hydrocortisone 1% cream/ointment (generic equivalents) and hydrocortisone 0.5% preparations.

Skin Condition

Eczema, Dermatitis, Insect Bites, Skin Rashes

Steroid Potency

Mild

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