Silkron Medicated Cream 10g

Product Information

• Dosage form: Topical cream
• Appearance: White to off-white cream
• Net weight: 10g
• Package: 1 tube × 10g
• Status: Prescription medicine (Rx)
• Application: External use only
• Manufacturer: Dong Kwang Pharm Co., Ltd.
• Country of origin: South Korea

Active Ingredients

According to the supplied packaging, each 10g contains:

• Clotrimazole: 100mg
• Betamethasone dipropionate: 6.4mg
• Gentamicin sulfate: 10mg potency

Clotrimazole is an imidazole antifungal, betamethasone dipropionate is a glucocorticoid corticosteroid, and gentamicin sulfate is an aminoglycoside antibiotic.

For a detailed breakdown of the formula, see Silkron Cream Ingredients.

Inactive Ingredients

The supplied package insert also lists:

• Cetanol
• Stearyl alcohol
• Liquid paraffin
• Polysorbate 60
• Sorbitan monostearate
• Propylene glycol
• Citric acid hydrate
• Disodium edetate hydrate
• Methyl paraben
• Propyl-paraben
• Purified water

Official Indication Information

The supplied Vietnamese package insert describes use for bacterial or fungal infection and for corticosteroid-responsive skin diseases associated with infection.

Conditions listed in the supplied insert include:

• Allergic dermatitis
• Contact dermatitis
• Atopic dermatitis
• Seborrheic dermatitis
• Eczema
• Intertrigo or diaper-type rash
• Exfoliative or scaly dermatitis
• Chronic lichen simplex (neurodermatitis)

The supplied English outer box additionally lists fungal conditions including trichophytosis, tinea pedis, tinea corporis, tinea faciei, tinea capitis, tinea sycosis, pityriasis versicolor and skin candidiasis.

These label indications should not be interpreted as meaning the medicine is appropriate for every rash or suspected skin infection. See Silkron Cream Uses for the full label-based overview.

Contraindications

The supplied insert lists several situations in which the medicine should not be used, including:

• Wounds or mucous membranes
• Certain primary bacterial, fungal, viral or parasitic skin infections
• Hypersensitivity to the medicine or any ingredient in the formula
• Hypersensitivity to aminoglycoside antibiotics
• History of hypersensitivity to imidazoles
• External-ear eczema with perforation of the tympanic membrane
• Certain skin ulcers and second-degree or more severe burns
• Perioral dermatitis
• Acne vulgaris
• Rosacea

For the complete contraindication and precaution information, see Silkron Safety & Precautions.

Important Precautions

The package insert states that topical corticosteroids can be absorbed systemically. In some patients, systemic absorption may cause reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis and other corticosteroid-related effects.

The insert gives particular attention to prolonged treatment, large treatment areas, damaged skin and occlusive conditions. It also contains precautions concerning concurrent exposure to systemic aminoglycoside antibiotics.

Possible Side Effects

The official insert lists possible local reactions including:

• Skin irritation
• Stinging or burning
• Rash
• Erythema or redness
• Warm or flushing sensation
• Itching
• Dry skin
• Folliculitis
• Boils
• Purulent dermatitis
• Allergic contact dermatitis
• Sweating
• Worsening skin lesions
• Ulceration

Steroid-related reactions listed in the insert include steroid pustules, steroid acne, perioral dermatitis, ichthyosis-like or scaly changes, hypertrichosis and hyperpigmentation.

The adverse-effect information also lists HPA-axis suppression, renal impairment and reduced hearing. The supplied insert does not assign one frequency category to every listed reaction, so these effects should not be assumed to occur with equal likelihood.

See Silkron Side Effects for the adverse-effect information organized by category.

Pregnancy and Breastfeeding

The supplied insert states that safety during pregnancy has not been established and states that the medicine should not be used in pregnant women or women who may become pregnant.

For breastfeeding, the insert states that it is unknown whether topically applied corticosteroids are excreted into breast milk and advises caution.

Children

The package insert calls for particular caution in neonates and children, especially in connection with prolonged treatment and aminoglycoside-related toxicity concerns.

Interactions and Compatibility

The supplied insert reports no established drug interactions, but separately warns that concurrent systemic aminoglycoside exposure may increase toxicity through accumulation.

Compatibility studies are not available. The insert therefore states that the medicine should not be mixed with other medicines.

Driving and Operating Machinery

The supplied package insert reports no evidence of an effect on the ability to drive or operate machinery.

Overdose Information

The supplied insert states that symptoms of overdose are unclear or unknown and that suspected overdose requires appropriate medical assessment and monitoring.

Storage

• Keep the container tightly closed.
• Store in a dry place.
• Protect from light.
• Store at a temperature not above 30°C.
• Keep out of reach of children.

Shelf Life

The stated shelf life is 36 months from the manufacturing date. Refer to the expiry information printed on the individual package.

Manufacturer

Dong Kwang Pharm Co., Ltd.
115 Sandan-ro, Pyeongtaek-si, Gyeonggi-do, Korea

For company background, see Dongkwang Pharmaceutical: The Korean Manufacturer Behind Silkron.

More Silkron Information

• Silkron Ingredients
• Silkron Safety & Precautions
• Silkron Side Effects
• Silkron FAQ
• Complete Silkron Guide

Important Information

This page summarizes information printed on the supplied packaging and package insert. Always rely on the current label and insert supplied with the medicine where product information differs.