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Tiamol Cream 0.05% Product Monograph

Status:
Prescription (Rx) Facts
Strength:
0.05 %
Active ingredient:

Product Monograph - Tiamol Cream 0.05%

PRECAUTIONS

Although side effects are not ordinarily encountered with topically applied corticosteroids, as with all drugs, a few patients may react unfavorably under certain conditions. Should symptoms of hypersensitivity or idiosyncrasy occur, the medication should be discontinued and appropriate steps taken.

If the lesion is infected the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid cream should be discontinued until the infection has been adequately controlled.

If extensive areas are treated, the -possibility exists of increased systemic absorption requiring that the amount applied and frequency of application be suitably adjusted. Patients should be advised to inform other physicians attending them of their use of corticosteroids.

Causal factors of dermatoses should be eliminated whenever possible.

It is recommended that rotation of sites of application and intermittent therapy should be considered.

Application in or near the eye should be avoided.

Prolonged use of topical corticosteroid products may produce atrophy of the skin and of subcutaneous tissues, particularly on flexor surfaces and on the face. If this is noted, discontinue the use of this product.

Fluocinonide should be used with caution in patients with stasis dermatitis and other skin diseases associated with impaired circulation.

During the use of topical corticosteroids secondary infections may occur.

ADVERSE EFFECTS

The following adverse skin reactions have been reported with the use of topical steroids: dryness, itching, burning, local irritation, striae, skin atrophy, atrophy of the subcutaneous tissues, telangiectasia, hypertrichosis, change in the pigmentation and secondary infection.

Adrenal suppression has also been reported following topical corticosteroid therapy.

Posterior subcapsular cataracts have been reported following systemic use of corticosteroids.

DOSAGE

Suitable when an emollient effect is desired. A small amount is applied lightly to affected skin area 2 to 4 times daily with gentle but thorough massage.

HOW SUPPLIED

Each gram of cream contains: fluocinonide 0.05% in an emollient base. Nonmedicinal ingredients: cetyl alcohol, citric acid, mineral oil, polysorbate-60, propylene glycol, sorbitan monostearate, stearyl alcohol and white petrolatum. Jars of 100g. Tubes of 25g.

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 00598933

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Drug information for Tiamol Cream 0.05%

Rx or OTC
Prescription (Rx)?
DIN 00598933
Schedule(s) PRESCRIPTION
Active ingredient(s) Fluocinonide 0.05 %
Dosage form(s) Cream
Route(s) of administration Topical
Drug class (WHO ATC)
  1. D Dermatologicals
    1. D07 Corticosteroids, dermatological preparations
      1. D07A Corticosteroid dermatological preparations, plain
        1. D07AC Corticosteroids, potent (group III)
          1. D07AC08 Fluocinonide
Company TAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC.
Current status Marketed
Current status date April 6, 2004

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.