FLUODERM® CREAM

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

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Patient Information leaflet

                                INDICATIONS [/za_1089.html#1]
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CONTRA-INDICATIONS [/za_1089.html#1]
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DOSAGE [/za_1089.html#1]
      [/za_1089.html#1]
SIDE-EFFECTS [/za_1089.html#1]
  [/za_1089.html#1]     [/za_1089.html#1]
PREGNANCY [/za_1089.html#1]
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OVERDOSE [/za_1089.html#1]
    
IDENTIFICATION [/za_1089.html#1]
  [/za_1089.html#1]    PATIENT INFORMATION
FLUODERM® OINTMENT
FLUODERM® CREAM
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
FLUODERM
®
 OINTMENT
FLUODERM
®
 CREAM
COMPOSITION:
 
Each 5 g ointment contains 1,25 mg 
FLUOCINOLONE ACETONIDE
.
 
Each 5 g cream contains 1,25 mg fluocinolone acetonide
 
Fluoderm Cream is preserved with 0,1% m/m chlorocresol.
PHARMACOLOGICAL CLASSIFICATION:
A 13.4.1 Corticosteroids with a without anti-infective agent.
PHARMACOLOGICAL ACTION:
Fluocinolone acetonide is a potent topical corticosteroid which exhibits anti-inflammatory, vasoconstrictive, anti-pruritic
and anti-allergic properties when applied locally to the skin and mucosa.
INDICATIONS:
Steroid responsive dermatoses.
CONTRA-INDICATIONS:
Corticosteroids have been shown to be teratogenic in animals following dermal application. As agents are absorbed
percutaneously teratogenicity following topical application cannot be excluded. Therefore Fluoderm should not be used
during pregnancy. Fluoderm is contra-indicated in the treatment of herpes simplex, vaccinia or varicella. Long-term use
is contra-indicated in patients with diabetes mellitus or tuberculosis. Fluoderm should not be used on infants and
young children.
WARNING:
FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN.
DOSAGE AND DIRECTIONS FOR USE:
FLUODERM
OINTMENT:
Apply to the affected areas 2 to 3 times daily by gentle inunction or use with occlusive dressings.
FLUODERM CREAM:
Apply to the affect
                                
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