Information Leaflet

Before using Monderma’s custom formula, please read the information in this leaflet carefully.

Monderma’s custom formula contains a combination of active pharmaceutical ingredients, excipients, and a base cream, and is formulated to treat facial acne, ageing skin, hyperpigmentation, or rosacea. It can only be obtained through an online consultation with a GMC or GPhC registered prescriber by adults over the age of 16.

Each custom formula is a 15g prescribed off-white cream packaged in an airtight pump container.

Active Pharmaceutical Ingredients

Monderma uses two to three of the following active pharmaceutical ingredients in each custom formula to target a specific skin concern:

Adapalene: a retinoid, vitamin A derivative, used to regulate the growth of cells on the surface of the skin to improve its texture and tone.

Azelaic acid: an anti-inflammatory used to inhibit the production of inflammatory-causing molecules to reduce redness and irritation.

Clindamycin: an antibiotic used to fight bacteria on the skin to reduce bumps and swelling.

Hydroquinone: a skin lightening agent used to reduce the production of melanin to lighten patches of darker skin.

Ivermectin: an antiparasitic agent used to decrease the number of Dermodex mites to reduce redness and swelling.

Niacinamide: an antioxidant, vitamin B3, used to eliminate free radicals by repairing and strengthening the barrier function of the skin to lock in moisture.

Tretinoin: a retinoid, vitamin A derivative, used to regulate the growth of cells on the surface of the skin to improve its texture and tone.

The pump container and box both have a dispensing label listing the active pharmaceutical ingredients, strengths, directions for use, and safety information.

Excipients

Monderma uses the following excipients in some instances to enhance the properties of the active pharmaceutical ingredients:

Butylated hydroxytoluene: an antioxidant and preservative used to prevent the growth of bacteria, yeast, and mould to stabilise and extend shelf life.

Citric acid: an antioxidant and preservative used to regulate the pH level of the formulation to maintain the barrier function of the skin.

Sodium metabisulfite: an antioxidant and preservative used to prevent oxidation and contamination to reduce discolouration.

Each custom formula with tretinoin contains butylated hydroxytoluene, while each custom formula with hydroquinone contains citric acid and sodium metabisulfite.

Base Cream

Monderma uses a base cream containing the following ingredients in each custom formula to provide and retain moisture, improve absorption, reduce inflammation, and decrease sebum production:

Water, 1,3-propanediol, edetate disodium dihydrate, hyaluronic acid, candelilla/jojoba/rice bran polyglyceryl-3 esters, glyceryl stearate, cetearyl alcohol, sodium stearoyl lactylate, cetearyl alcohol, undecane, tridecane, simethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, c13-14 isoalkane, polysorbate 80, decyl glucoside, glycerin, phenoxyethanol, ethylhexylglycerin, hydroxycinnamic acid, bisabolol, butylene glycol, dextran, palmitoyl tripeptide-8, persea gratissima oil, simmondsia chinensis seed oil, rosa canina flower oil, tocopheryl acetate, cocos nucifera oil, lavandula angustifolia herb oil, melaleuca alternifolia leaf oil, rosemarinus officinalis leaf oil, butyrospermum parkii butter, and caprylic/capric triglyceride.

Each custom formula is highly spreadable, has a light feel, and is suitable for all skin tones and types. It is free of dyes, parabens, mineral oils, sodium lauryl sulfate, propylene glycol, and petroleum.

Apply TWO pumps on clean, dry skin to the affected area(s) daily at NIGHT. Thoroughly cleanse hands after use and apply moisturiser directly afterwards.

Treating the skin requires patience and consistent use. Allow up to 12 weeks for visible results.

Take the following precautions when using the custom formula:

• Do not use if allergic to any of the active pharmaceutical ingredients listed on the dispensing label, excipients, or ingredients in the base cream.
• For external use only; do not swallow.
• Avoid eyes, nostrils, lips, and other sensitive areas.
• Do not apply to sunburned or broken skin.
• Avoid the use of other topical or oral retinoids.
• Apply sunscreen daily with a minimum of SPF30, even on cloudy days, and do not use sunbeds.
• Stop using immediately if you are trying to conceive, become pregnant, or are breastfeeding.
• Do not share with anybody else.

The custom formula is not known to affect the ability to drive or use machinery.