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Retisol-A: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Post Market
Strength:
0.1 % / 7.5 % / 2 %, 0.025 % / 7.5 % / 2 %, 0.01 % / 7.5 % / 2 %, 0.05 % / 7.5 % / 2 %
Active ingredients:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Retisol-A

What the medication is used for:

RETISOL-A® topical cream is used in the treatment of acne. RETISOL-A® is not effective in most cases of severe acne.

RETISOL-A® topical cream is not for use in children under 12 years of age or in adults over 65 years of age.

What it does:

RETISOL-A® topical cream is believed to accelerate skin growth and turn-over of cells and increase the flow of cellular debris such as dead skin cells and oils to the surface for elimination, thereby helping to reduce the acne condition.

RETISOL-A® topical cream also contains sunscreens (octinoxate and avobenzone) which may provide limited sun protection for a limited time.

When it should not be used:

Do not use RETISOL-A® topical cream if you are allergic to tretinoin, retinoids, octinoxate, avobenzone or to any of the other ingredients of RETISOL-A® cream (see What the nonmedical ingredients are).

What the medicinal ingredients are:

RETISOL-A® topical cream contains tretinoin, in strengths of 0.01%, 0.025%, 0.05%, or 0.1% (Forte), with sunscreens octinoxate 7.5% w/w and avobenzone 2% w/w.

What the nonmedicinal ingredients are:

RETISOL-A® topical cream contains Elefac I-205, glycerin, diisopropyl adipate, stearyl alcohol, sorbitan monostearate, D.C. Fluid Nos. 556 and 344, light mineral oil, polysorbate 60, carbopol 934, germaben II, butylated hydroxytoluene, sodium hydroxide as pH adjustor and purified water.

What dosage forms it comes in:

RETISOL-A® topical creams, in strengths of 0.01%, 0.025%, 0.05%, or 0.1% (Forte), are available in 45 g tubes.

WARNINGS AND PRECAUTIONS

BEFORE you use RETISOL-A® topical cream talk to your doctor or pharmacist if:

  • You are currently or about to start using any other acne or skin medications.
  • You have had a previous reaction to any other acne or skin medication.
  • You have a family history of skin cancer.
  • You have any other skin condition, such as eczema, any inflammatory skin condition, photoallergy, sensitive skin, or a fair complexion.
  • You have any ongoing skin irritation. This irritation should be resolved before starting treatment with RETISOL-A®.

  • You are pregnant or planning to become pregnant.

    Topical tretinoin should not be used by pregnant women as rare birth defects have been reported with the use of topical tretinoin. It is not known if the birth defects were caused by topical tretinoin.

  • You are breastfeeding or planning to breastfeed.
  • You cannot avoid extensive exposure to sunlight, e.g., due to work requirements.

If you are a female of childbearing age, you should only use RETISOL-A® topical cream after consulting your doctor and seeking his/her advice for contraceptive counselling. If you are pregnant or nursing a child, you should discontinue the use of RETISOL-A® topical cream and consult your doctor. There is no information on how RETISOL-A® might affect fertility.

RETISOL-A® topical cream is for external use only. If you accidentally get RETISOL-A® on irritated skin, in the eyes, mouth or lips, rinse the affected area immediately with plenty of water.

Avoid or minimize exposure to sunlight and sun lamps because RETISOL-A® topical cream heightens the susceptibility of your skin to the adverse effects of the sun. RETISOL-A® contains sunscreens and may provide limited sun protection for a limited time.Use of a broad spectrum sunscreen with a sun protection factor (SPF) of at least 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. If you have a sunburn, allow the sunburn to settle before starting treatment with RETISOL-A®. If sunburn occurs while using RETISOL-A®, stop using RETISOL-A®and call your doctor for advice.

Extreme weather (e.g. cold or wind) may irritate your skin, avoid or minimize exposure.

Stop treatment and see your doctor if skin irritation is severe (severe redness, dryness, itching, stinging or burning) or your acne does not improve.

INTERACTIONS WITH THIS MEDICATION

Some medicines, skin procedures, or cosmetic products may affect how RETISOL-A® topical cream works and may make it more likely that you will have side effects. Some of these may include:

  • Other acne or skin preparations including peeling

    agents (e.g. sulfur, resorcinol, salicylic acid). If irritation or dermatitis (redness, peeling, or discomfort) occurs, reduce the number of times you apply RETISOL-A® or temporarily stop using RETISOL-A®. Start using RETISOL-A® again when the irritation goes away.

  • Drugs that make you more sensitive to light (e.g.

    thiazides, tetracycline, fluoroquinolones, phenothiazines, sulphonamides).

  • Drugs that contain benzoyl peroxide.

  • Skin procedures such as depilation, chemical hair

    treatments, chemical peels, dermabrasion or laser resurfacing. Following these procedures, allow skin to recover before starting treatment with RETISOL-A®.

  • Cosmetics or skin products that have a strong drying

    effect (e.g., products with a high alcohol content, astringents, skin drying agents, after shave lotions) as they may irritate your skin. It is best to use only water-based cosmetics.

  • Cosmetic products that have a potential irritating

    effect (e.g., abrasive agents, products containing spices or limes).

Tell your doctor or pharmacist about all your other medications, including those you can buy without a prescription as well as herbal and alternative medications.

PROPER USE OF THIS MEDICATION

RETISOL-A® topical cream should only be applied to your skin.

If your doctor recommends (prescribes) another topical acne product, this should be applied at a different time of day as RETISOL-A® topical cream.

Do not apply RETISOL-A® to areas of skin where you have problems such as eczema, severely inflamed skin or other open lesions.

Do not use on sensitive, areas such as irritatied skin,eyes, mouth, lips, angles of nose, and corners of eyes and mouth, and mucous producing areas.

How to Apply RETISOL-A® Topical Cream:

  1. 1.

    Wash your hands thoroughly before applying

    RETISOL-A®.

  2. 2. Completely remove any make-up.
  3. 3. Wash affected area gently with warm water and a mild, non-irritating soap or cleanser, and pat dry.
  4. 4. Apply RETISOL-A® sparingly and evenly once daily, as prescribed by your physician. Use your finger-tip to apply enough to cover the required area, and smooth in. Allow your skin to dry fully before applying cosmetics.
  5. 5.

    Wash your hands thoroughly after applying

    RETISOL-A®

At the beginning, you may experience redness, a burning sensation, peeling, or possibly a worsening of your acne, while your skin adjusts to the medication.

Your doctor may recommend a daytime moisturizer if your skin is particularly dry.

To minimize these reactions, your doctor may start you on the mildest strength of RETISOL-A® and go up gradually until you reach the strength that your doctor feels is most suitable for your skin type. Your doctor may advise you to apply the RETISOL-A® less frequently than every day.

It takes several weeks of regular use of RETISOL-A® before you can expect noticeable improvement and 8-10 weeks for optimal results, so be patient. Treat your acne with RETISOL-A® for as long as your doctor tells you.

Applying too much or applying it more frequently will not help your skin clear up more quickly, and may cause skin irritation.

It is important to understand that your doctor has given you a prescription specially suited to your particular needs and skin type. Do not allow others to use it. Always use RETISOL-A® exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Overdose:

In case of drug overdose, contact your healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.

If you accidentally swallow RETISOL-A®, seek medical advice.

Missed Dose:

If you forget to apply RETISOL-A® topical cream at your

regular time, apply RETISOL-A® at the next usual time. Do not apply more than once a day to make up for forgotten applications.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

During the first weeks of using RETISOL-A® topical cream, you may notice some skin irritation such as redness and skin flaking. These symptoms will normally subside if you use RETISOL-A® less often or stop using it for a few days and then start again.

Other side effects that have been reported are: skin pain, itching/itchy skin, skin irritation, tenderness, warm skin, especially when first applied, stinging or burning sensation, dry skin, swelling at the site of application, rash at the site of application, redness at the site of application, skin blistering, skin crusting, allergic reaction, darkening of skin, lightening of skin, sensitivity to sunlight and skin thinning. Talk to your doctor if any of the side effects become severe or troublesome.

Severe skin reactions (severe burning, peeling or itching of your skin) have also been reported. Stop taking RETISOL-A® and contact your doctor immediately if you get any of these symptoms.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect

Talk with your

doctor or pharmacist

Stop

taking drug and call your doctor or pharmacist

Only if severeIn all cases
Rare

Allergic reaction: difficulty

breathing or

swallowing caused by sudden

swelling of the throat, face, lips or mouth or notice sudden swelling of hands, feet and ankles, or an itchy rash (hives)

✓

This is not a complete list of side effects. For any unexpected effects while taking RETISOL-A® topical cream contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15°C and 25°C. Do not freeze. Keep the tube tightly closed when not in use. Keep out of the sight and reach of children.

REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

--------------------------------------------------------------------------

  1. 1. Report online at www.healthcanada.gc.ca/medeffect
  2. 2. Call toll-free at 1-866-234-2345
  3. 3.

    Complete a Canada Vigilance Reporting Form and:

    • Fax toll-free to 1-866-678-6789, or

    • Mail to: Canada Vigilance Program Health Canada

      Postal Locator 0701E Ottawa, Ontario

      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.stiefel.ca or by contacting the sponsor,

GlaxoSmithKline Inc.

7333 Mississauga Road

Mississauga, Ontario

L5N 6L4

1-800-387-7374

Last revised: April 9, 2014

© 2014 GlaxoSmithKline Inc. All Rights Reserved ® RETISOL-A is a registered trade-mark owned by GlaxoSmithKline Inc.

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02008726

Revision date stated in the text: April 9, 2014

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Retisol-A

Rx or OTC
Prescription (Rx)?
DIN 02008726, 02008696, 02008688, 02008718
Schedule(s) PRESCRIPTION
Active ingredient(s) Tretinoin, Octinoxate, Avobenzone
Dosage form(s) Cream
Route(s) of administration Topical
Drug class (WHO ATC)
  1. D Dermatologicals
    1. D10 Anti-acne preparations
      1. D10A Anti-acne preparations for topical use
        1. D10AD Retinoids for topical use in acne
          1. D10AD51 Tretinoin, combinations
Company GLAXOSMITHKLINE INC
Current status Cancelled Post Market
Current status date July 3, 2015
Strengths and forms
DIN Strength Dosage form(s) Current status
02008726 0.1 % / 7.5 % / 2 % Cream Cancelled Post Market July 3, 2015
02008696 0.025 % / 7.5 % / 2 % Cream Cancelled Post Market July 3, 2015
02008688 0.01 % / 7.5 % / 2 % Cream Cancelled Post Market July 3, 2015
02008718 0.05 % / 7.5 % / 2 % Cream Cancelled Post Market July 3, 2015

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.