Sudocrem Image

About Sudocrem

Technical information

  1. Trade Name of the Medicinal Product

    SUDOCREM ANTISEPTIC HEALING CREAM

  2. Qualitative and Quantitative Composition

     % w/w
    Zinc oxide, EP15.25
    Benzyl alcohol, BP0.39
    Benzyl benzoate, BP1.01
    Benzyl cinnamate0.15
    Lanolin (hypoallergenic)4.00

  3. Pharmaceutical Form

    Emulsified water in oil cream

  4. Clinical Particulars

    1. Therapeutic Indications

      In the treatment of:

      1. Napkin rash
      2. Eczema
      3. Bedsores
      4. Acne
      5. Minor burns
      6. Surface wounds
      7. Sunburn
      8. Chilblains

    2. Posology and Method of Administration

      Apply a thin layer with suitable covering where necessary. Renew application as required. No distinction is required between indications or between adults, children and the elderly.

      Topical cream for external use only.

    3. Contra-indications

      Hypersensitivity to any of the ingredients.

    4. Special Warnings and Precautions for Use

      For external use only and should not be allowed to come into contact with the eyes and the mucous membranes.

    5. Interactions with Other Medicaments and Other Forms of Interaction

      None known

    6. Pregnancy and Lactation

      There are no known contra-indications

    7. Effects on Ability to Drive and Use Machines

      Not applicable

    8. Undesirable Effects

      Side effects include local hypersensitivity occasionally.

    9. Overdose

      No cases of overdose have been reported. If large amounts are swallowed accidentally, this may cause vomiting, diarrhoea, CNS stimulation and convulsions. Symptomatic treatment should be provided.

  5. Pharmacological Properties

    1. Pharmacodynamic Properties

      Zinc oxide:
      A dermatological agent with astringent, soothing and protective properties.

      Benzyl alcohol:
      A local anaesthetic with disinfectant properties.

      Benzyl benzoate:
      An acaricide and has been used as a pediculicide, insect repellent and pharmaceutical solubilising agent. It is a constituent of many natural balsams and is one of the principal esters of Peru Balsam.

      Benzyl cinnamate:
      This is the other principal ester of Peru Balsam BPC 1973. It is synthesised from benzyl alcohol and cinnamic acid which has antibacterial and antifungal properties. Peru Balsam is categorised as having a mild antiseptic action because of cinnamic acid and its derivatives present.

      Lanolin (hypoallergenic):
      Resembles the sebaceous secretions of human skin. The grade used is manufactured so as to exclude many sensitising substances present in the lanolin.

    2. Pharmacokinetic Properties

      Not applicable

    3. Preclinical Safety Data

      Not applicable

  6. Pharmaceutical Particulars

    1. List of Excipients

      Purified Water
      Sodium Benzoate
      Paraffin wax
      Microcrystalline wax
      Heavy Liquid Paraffin
      Synthetic Beeswax
      Sorbitan sesquioleate
      Propylene glycol
      Embanox 4
      Linalyl acetate
      Lavender

    2. Incompatibilities

      None known

    3. Shelf Life

      5 years

    4. Special Precautions for Storage

      None

    5. Nature and Contents of Container

         Pack size (g)
      a)Polypropylene jars with polyethylene tamper-evident caps(1)60
        (2)120
        (3)250
        (4)400
      b)polypropylene jar with polyethylene cap(1)25
        (2)15
      c)aluminium or laminated plastic aluminium tubes with aluminium membrane andplastic cap 30

    6. Instructions for Use/Handling

      Not applicable

  7. Marketing Authorisation Holder

    Tosara Products (UK) Limited
    PO Box 20
    Liverpool L18 9XS

  8. Marketing Authorisation Number

    PL 3430/0001R

  9. Date of First Authorisation/Renewal of Authorisation

    Renewal August 1996

  10. Date of (Partial) Revision of the Text

    September 1996

  11. Legal Category

    GSL