Product

DEPIGMEN

  • Description
  • HOW TO USE
  • WARNING AND CAUTION

Product Description

Compositions
2% Mequinol and 0.01% Tretinoin

Mechanism of Action

Mequinol works by oxidizing tironase enzymatically into cytotoxic products in melanocytes resulting in degradation / destruction of pigment cells – the effect of depigmenting. Tretinoin acts on tyrosinase by inhibiting enzyme transcription as well as conversion factor in dopacrom, which leads to disruption of melanin synthesis. Tretinoin also reduces hyperpigmentation by inducing desquamation

Indications
solar lentigines treatment (hyperpigmentation because ultraviclet ray exposure).

Contraindications 

  • Pregnant and lactating mother.
  • Patient treated with photosensitizer substance, including thiazides, tetracyclin, fluoroquinolones, phenothiazides, sulfonamides.
  • Patient with sensitivity reaction history on active and additive Substances in Depigmen. Stop this product usage in case of hypersensitivity reaction.

Storage

Packaging
Dus, Bottle 30ml

ON MEDICAL PRESCRIPTION ONLY

Manufactured by

PT. Surya Dermato Medica Laboratories, Surabaya

Indonesia

Reg. No. POM DKL1028605141A1

Patient should familiar with this product application in detail to have maximal result, and comprehend all precautions as of applying it safely, Physician must review information for the patient. Apply Depigmen Solution on Solar Lentigines with applicator tip and avoid extensive application to the surrounding skin. Apply twice a day, in the morning and at night with 8 hour interval, or as prescibed by the physcian. Patient is suggested for not washing or rinsing the administered area of 6 hour minimal after its application. Do not apply this product on eyes, mouth, paranasal creases, mucous membranes. Depigmen Solution application may cause temporary sting, burn sensation, or irritation. Gradual recovery happened during therapy, and observable on the 24th weeks. Patient is suggested to avoid Sunray exposure (including UV light) or to use protective clothing during its application. No appropriate data available on how Depigmen Solution could be decomposed (both by Ultraviolet ray or normal interior lamp) during its application on skin, Depigmen Solution therapy discontinuation in majority patients may cause re - pigmentation the lesion. Large amount, or more frequent application will not accelerate the recovery, or better result, even may cause redness, peeling, irritation or hypopigmentation (abnormal whitening). Patient applying Depigmen Solution may apply cosmetics 30 minutes later. Unverified security and effectiveness data of Depigmen Solution to prevent and treat melasma and Post inflammatory hyperpigmentation. Unverified efficacy of Depigmen Solution for more than 24 weeks daily application.

  • Do not apply to sensitive patient to acitretin, etrinate, isotretinoin, or other Vitamin Adcrivatives.
  • Do not apply for more than 52 weeks (long term). Tretinoin is reported to cause severe skin irritation with eczema and may only be applied with special attention for patient with this condition. In case of irritation, immediately decrease the application of this preparation. In case of further irritation, immediately seek medical advice.
  • Overdose application will not accelerate the recovery process, but even may cause severe irritation, including redness, peeling skin, inconvenient or hypopigmentation.
  • Do not apply on burning skin. Wait until thoroughly recover,
  • Carefully apply to Patient with vitiligo history
  • Avoid application on mouth, eyes, and mucous membranes surrounding areas
  • During the application of this preparation, wear protective clothing to avoid Sunray direct contact / eliminate its exposure. Apply sunscreen 30 minutes later after applying this preparation. Patient with burn skin because of sunray exposure is not suggested to apply this product until totally recover. Patient who is considered to be exposed to Ultraviolet ray because of his job, and patients who is sensitive to Ultraviolet ray must be extra careful when applying this product, and ensure that all information of precautions / Warnings have been met.
  • Depigmen Solution may not be combined with other photosensitizers products (for example: thiazides, tetracyclines, fluoroquinolones, phenotazines, sulfonamides) as it may increase the phototoxicity.
  • Depigmen Solution may cause skin irritation, erythema, burn or poignant sensation, peeling skin, and itchiness. In case one of the said reaction manifestation shall occur, Patient is suggested for reducing the amount, and frequency of usage, temporary, or totally stop the treatment. Unverified efficacy on frequency reduction.

General:

For external use only. Depigmen solution may only be applied as a comprehensive skin care program addition, and Sunray avoidance. Stop application in case of sensivity, chemical irritation, or systellic side effects. This product is possibly more irritating in extreme weather, such as extreme wind or cold.

  • Administration for Geriatric: No thorough different effectiveness or Security appear on elderly or young patients,
  • Carcinogenic: Animal study presents the increase risk of tumor on the exposed retinoid to Ultraviolet radiation. Though unclear significancy between animal study and product application on human, Patient is suggested to avoid, or minimize the exposure of Ultravioletray, or other artificial Ultravioletirradiations.
  • Do not apply to children.
  • Flammable material, put away from open fire, and heat.
    • Combined usage with photosensitizer, such as fluoroquinolone, phenothiazines, sulfonamides, tetracycli Illes, thiazide diuretic may cause augmentin toxicity,
    • Combined usage with alcoholic products, or having strong drying effect, such as astringent, medicated soap/shampoo, permanent curly solution, electrolysis, wax, hair clipper immer, or other ly solution, electrolysis, , wax, hair clipper/ trimmer, or other
    • SIDE EFFECTS :
      • Frequent case: irritation, erythema, burn and poignant sensation, itchiness on surrounding administered area, dryness / peeling skin.
      • possible temporary hypopigmentasi on treated lesion, and it may return to normal after a while upon treatment discontinuation.

      PRODUCT INTERACTION:

    • irritating preparation or drying skin should be carefully applied on patient administered with Depigmen, as combined material may increase the irritation.