The Hydroquinone + Tretinoin + Hydrocortisone Patient Information Leaflet
Important information for Skin + Me customers.
This document contains important information about using the Skin + Me Hydroquinone + Tretinoin + Hydrocortisone combination treatment. Before you click your first Daily Dose, please read all of the following information.
In this Patient Information Leaflet, you’ll find:
- How to use the Hydroquinone + Tretinoin + Hydrocortisone treatment
- Information about your active ingredients and the base creams
- Storage instructions and guidance
- How to report side effects
1. How to use the Hydroquinone + Tretinoin + Hydrocortisone treatment
Your Daily Doser contains 12ml of cream compounded by The Feel Good Pharmacy, Unit 5 Oakwood Business Park, Standard Road, London, NW10 6EX. The cream in your Daily Doser is prescribed for your skin, and only your skin. Please don’t share this treatment with anyone else, as it may cause harm.
- Your treatment is only ever for external use.
- Wash your face, and allow your skin to completely dry.
- Each ‘click’ of your Daily Doser is one dose to be used once a day, at night time. Do not use more treatment than prescribed, or more often or for longer than instructed. Doing so can increase your chances of suffering from side effects.
- Twist and click your Daily Doser for one dose of treatment and apply sparingly only to the affected (darker) areas of skin on your face, once at night.
- If you only have a few small dark spots, it’s best to apply the treatment with a cotton swab to avoid accidentally lightening the area around them.
- If you have a cluster of dark spots or a larger patch of hyperpigmentation, apply your treatment to the entire affected area with your fingertips.
- Dispose of any excess treatment from your Daily Doser and make sure to wipe your Daily Doser clean and wash your hands with soap and water, making sure you wash your fingernails if any of the treatment gets on them as it can lead to discolouration.
- Avoid applying your treatment on your eyelids, or around your eyes, nostrils, and mouth (the skin of the upper lip is fine to apply your treatment if affected).
- Don’t swallow your cream.
- If you miss a dose, just apply the following evening. Don’t double up on applications.
- If you notice that the skin around your dark spot has been unintentionally lightened, it’s best to stop using the treatment for a few weeks. Wait until the surrounding skin returns to its normal colour before resuming your treatment.
- It’s important to be consistent with sunscreen (at least SPF 50 with UVA and UVB protection) as the dark spots being targeted can worsen with sun exposure. Even minimal sun exposure can worsen these dark spots, and this can cancel out the effects of your treatment.
- It can take several weeks before you see initial improvements in your skin. The prescribed treatment plan should be followed as directed by your Prescriber and the initial treatment may be followed by a maintenance treatment, depending on how you respond to treatment and your follow-up consultation.
- Do not use your cream past the expiry date printed on your Daily Doser.
- The Hydroquinone + Tretinoin + Hydrocortisone treatment should NOT be used if you are pregnant, breastfeeding or trying to conceive.
- Do not use your treatment if you have a known allergy to any of the active ingredients or to the base creams (see section 3).
- If you develop an allergic reaction to your treatment then you must stop applying it. For your reference, signs of an allergic reaction may include rash; hives; itching; shortness of breath; wheezing; cough; swelling of the face, lips, tongue or throat.
- If in doubt, do not hesitate to ask your doctor or pharmacist for advice and call 999 in a medical emergency.
- Do not use the Hydroquinone + Tretinoin + Hydrocortisone treatment if you have any skin infections (such as cold sores, chicken pox, bacterial or fungal infections) or kidney disease.
- The Hydroquinone + Tretinoin + Hydrocortisone treatment should not be used to treat vitiligo, melanoma (or suspected melanoma), acute inflammation or eczema of the skin, perioral dermatitis or rosacea.
- Do not use the Hydroquinone + Tretinoin + Hydrocortisone treatment if you have a sulfite allergy as it contains sodium metabisulfite.
- Avoid using exfoliating products, soaps/cleaners with a strong drying effect, alcohol products and scented facial products as this may further irritate your skin. Avoid waxing whilst using this treatment.
3. Information about your active ingredients and the base cream
Your medication will contain a combination of the active ingredients listed below. Please refer to your Daily Doser, the box (or in your email) to determine which of these active ingredients are in your treatment, bearing in mind these will change over time.
Hydroquinone + Tretinoin + Hydrocortisone combination treatment
Drug use: used topically to treat hyperpigmentation disorders such as melasma. Hydroquinone stops melanocytes (pigment-producing cells) in the skin from making melanin - the substance that causes pigmentation of the skin. Tretinoin increases the turnover of new skin cells and helps the hydroquinone penetrate the skin. Hydrocortisone prevents and reduces inflammation of the skin.
Side effects: 1. Mild irritation, flaking and stinging are common where the cream is applied but are usually temporary and settle when the cream is stopped 2. Prolonged application (more than 3 months) can cause thinning of the skin and persistent redness of the skin. 3. Prolonged application (more than 3 months) can cause both pale marks and dark marks (called ochronosis) on the skin. 4. This treatment can cause unintentional lightening of the skin surrounding the darker areas you're trying to treat, which is why we advise treating the affected areas (rather than the whole face). To minimise risk of side effects i’s important to use this treatment as directed by your Prescriber.
Sunlight on your skin may reverse the effect of the cream. You should therefore avoid excessive exposure to sunlight and avoid all use of sun lamps and sun beds. If you are going to be exposed to direct sunlight, ensure you cover the area and wear sunscreen with a high factor (at least factor 30). You should do this during and following treatment. If travelling abroad for a sunny holiday stop using the cream one week before departure.
The Hydroquinone + Tretinoin + Hydrocortisone combination cream should not be applied: near your eyes or around the eyelid area; to cut, broken or sunburned skin; after shaving or using depilatory agents (hair removers); to skin that is affected with a rash or any skin infections (such as cold sores, chicken pox, fungal and bacterial infections).
WARNING: TRETINOIN MAY CAUSE HARM TO AN UNBORN BABY IF TAKEN WHILE PREGNANT. IF YOU ARE PREGNANT, BECOME PREGNANT OR ARE PLANNING A PREGNANCY WHILST USING THIS MEDICATION OR WITHIN ONE MONTH AFTER STOPPING TREATMENT, PLEASE CONTACT YOUR DOCTOR. PLEASE ENSURE ADEQUATE CONTRACEPTION IS TAKEN WHILST USING THIS MEDICATION AND STOP ONE MONTH BEFORE TRYING TO CONCEIVE.
Our base creams
We have two base creams and the ingredients for each are listed below.
Our base creams are light, non-greasy, hydrophilic gel creams and are non-comedogenic. They are fragrance free, and contain vitamin E and oil from the safflower seeds which give them antioxidant and skin-moisturising properties. They are perfectly suited to the needs of oily, balanced and affected skin, and free of harmful, obsolete and controversial ingredients.
Base cream 1: Aqua, Carthamus Tinctorius Oleosomes, Polyacrylate-13, Polyisobutene, Sodium Carbomer, Gluconolactone, Polysorbate 20, Sorbitan Isostearate, Benzoic Acid, Sorbic Acid, Tocopheryl Acetate, Sodium Benzoate.
Base cream 2: Aqua, Carthamus Tinctorius Seed Oil, Tocopheryl Acetate, Polyacrylate-13, Polyisobutene, Sodium Carbomer, Polysorbate 20, Sorbitan Isostearate, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Ethylhexylglycerin,
Both base creams are free from: animal testing, GMO products, animal products or derivatives. They are vegan-friendly and cruelty-free and contain no dairy, eggs, nuts, gluten, soy, corn, celery or mustard products.
If you experience any undesirable effects, talk to your GP or dermatologist. This applies to any undesirable effect that is not mentioned within this leaflet.
4. Storage instructions and guidance
KEEP THIS MEDICATION OUT OF SIGHT AND REACH OF CHILDREN.
- Do not flush unused medication or pour it down the sink, and do not place it in the general waste bin. Please ask your pharmacist what to do with unused medication. These measures are in place to help the environment.
- Store in a cool dry place below 25-degree Celsius and out of direct sunlight.
- Do not use your medication after the expiry date which is shown on the Daily Doser.
5. How to report side effects
If you experience any unwanted side effects, you should contact us via the Dermatology Support team or talk to your GP or healthcare professional. Also, you can help to make sure medicines remain as safe as possible for everyone by reporting any unwanted side effects at www.mhra.gov.uk/yellowcard. Alternatively, you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.