The Standard Patient Information Leaflet (all treatments EXCEPT Hydroquinone + Tretinoin + Hydrocortisone)

Important information for Skin + Me customers.

This document contains important information about using your Skin + Me treatment. Before you click your first Daily Dose, please read all of the following information. Please note if you have the Hydroquinone + Tretinoin + Hydrocortisone treatment you should read the information in the separate patient information leaflet found here.

In this Patient Information Leaflet, you’ll find:

  1. General treatment information
  2. Contraindications
  3. Information about your active ingredients and the base creams
  4. Storage instructions and guidance
  5. How to report side effects

1. General treatment information

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.

Applications + Usage

  • Your treatment is only ever for external use.
  • Wash hands before and after you apply your treatment.
  • 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 the metal bit of your Daily Doser until you hear the click, and apply a thin layer of the cream to your whole face avoiding the immediate eye area and mouth. If using the Hydroquinone, Tretinoin, Hydrocortisone treatment - this should only be applied to the affected darker areas of skin (see separate patient information leaflet).
  • Don’t swallow your cream.
  • If you miss a dose, just apply the following evening. Don’t double up on applications.
  • 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.

2. Contraindications

  • Treatments containing Tretinoin, Hydroquinone, Clindamycin and Metronidazole should NOT be used if you are pregnant, breastfeeding or trying to conceive.
  • Some of our treatments can be used when pregnant, breastfeeding or trying to conceive but your Prescriber will only prescribe in these circumstances if you have read our pregnancy information and agreed to treatment.
  • 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.

3. Information about your active ingredients and the base creams

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.

1. Tretinoin

Drug use: Used topically for acne, wrinkles, fine lines, texture and pigmentation.

Side effects: There may be a brief initial sensation of warmth or stinging immediately after applying this medication. Local side effects such as dry skin, redness, itching, rashes, irritation and mild peeling are common (seen in between one in 10 and one in 100 users). These effects tend to settle with time. More severe side effects such as swelling, blisters, skin burning sensation, skin discolouration, crusting and significant skin peeling may occur uncommonly (seen in between one in 100 and one in 1000 users). Rarely skin hyperpigmentation (darkening of the skin) and hypopigmentation (lightening of the skin) and severe allergic reactions can occur (seen in between one in 1000 and one in 10, 000 users). If you experience any of these more serious skin reactions please stop treatment and contact us for further advice, or speak to your GP or healthcare provider.

Do not use if your skin is sunburned.

You may find that your skin is more sensitive to sunlight and sunburns more easily.  An appropriate sunscreen (minimum SPF 30 with UVA and UVB protection) or protective clothing should be used daily whenever applying tretinoin. Avoid using sunbeds, tanning lamps and strong sun.

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.

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.

2. Azelaic Acid

Drug use: Used topically to treat acne, rosacea, hyperpigmentation and skin texture. 

Side effects: Occasionally local skin irritation may occur, usually at the start of treatment. In most cases the irritation is mild and usually gets better as treatment continues. Contact us if you have skin irritation that is severe, worsens or does not go away. There may be skin discolouration at the application site and skin lightening can occur, particularly in darker skin types. If you have asthma, in rare cases worsening of asthma has occurred.

3. Clindamycin

Drug use: Topical antibiotic used to treat acne.

Side effects: Local irritation such as burning, itching, dry skin and redness.
Caution: Do not use Clindamycin if you have a history of allergy to clindamycin, a history of Inflammatory Bowel Disease (IBD); Crohn’s disease, ulcerative colitis or antibiotic-associated colitis.

If you have ever experienced any of the following whilst previously using Clindamycin (oral or topical) or within a few months after stopping usage, please let us know: severe diarrhoea called antibiotic-associated colitis or regional enteritis OR a severe form of diarrhoea called C-difficile associated diarrhoea (CDAD).

Please stop using the medication and call your doctor immediately if you have stomach pain or cramps, very loose or watery stools, or bloody stools.
If you are taking medication which is a Vitamin K antagonist, such as warfarin, acenocoumarol, phenindione and heparin, you may need to increase the frequency of your coagulation tests (INR/PT).

4. Niacinamide

Drug use: Used topically to treat acne, pigmentation, rosacea and skin-ageing concerns for its barrier improving, anti-inflammatory and sebum-reducing properties.

Side effects: Niacinamide is usually very well tolerated but in rare occasions may cause mild stinging, redness or irritation.

5. Metronidazole 

Drug use: Metronidazole is used topically for its antimicrobial properties, for the treatment of the papules, pustules and redness associated with rosacea. 

Side effects: Localised and mild skin irritation, including dry skin. 

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 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,

All treatments containing Tretinoin will also contain the antioxidant BHT (butylated hydroxytoluene).

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.

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