Sudocrem Antiseptic Healing Cream: Indications, Dosage, Precautions, Adverse Effects
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Sudocrem Antiseptic Healing Cream - Product Information

Manufacture: Forest Laboratories, Inc.
Country: Great Britain
Condition: Acne, Bed Sores (Dermal Ulcer), Eczema, Minor Burns, Rash (Skin Rash), Sunburn, Wound Cleansing (Wound Debridement)
Class: Dermatological agents
Form: Cream
Ingredients: zinc oxide, benzyl alcohol, benzyl benzoate, benzyl cinnamate, lanolin (hypoallergenic), purified water, sodium benzoate, paraffin wax, microcrystalline wax, heavy liquid paraffin, synthetic beeswax, sorbitan sesquioleate, propylene glycol, antioxidant, linalyl acetate, lavender

Name of the Medicinal Product

Sudocrem Antiseptic Healing Cream

Qualitative and Quantitative Composition

  % w/w
Zinc oxide, EP 15.25
Benzyl alcohol, BP 0.39
Benzyl benzoate, BP 1.01
Benzyl cinnamate 0.15
Lanolin (hypoallergenic) 4.00

Pharmaceutical Form

Emulsified water in oil cream

Clinical Particulars

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

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.

Contraindications

Hypersensitivity to any of the ingredients.

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.

Interaction with Other Medicinal Products and Other Forms of Interaction

None known.

Pregnancy and Lactation

There are no known contraindications.

Effects on Ability to Drive and Use Machines

Not applicable.

Undesirable Effects

Side effects include local hypersensitivity occasionally.

Overdose

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

Pharmacological Properties

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 Balsal BPC 1973. It is synthetised 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 resembles the sebaceous secretions of human skin. The grade (hypoallergenic) used is manufactured so as to exclude many sensitising substances present in the lanolin.

Pharmacokinetic Properties

Not applicable.

Preclinical Safety Data

Not applicable.

Pharmaceutical Particulars

List of Excipients

Purified Water, EP

Sodium Benzoate, BP

Paraffin wax

Microcrystalline wax

Heavy Liquid Paraffin, BP

Synthetic Beeswax

Sorbitan sesquioleate

Propylene glycol, BP

Antioxidant (Formulation consisting of Butylated hydroxyanisole (BHA), citric acid and Propylene Glycol)

Linalyl acetate

Lavender

Incompatibilities

None known.

Shelf Life

Not exceeding 5 years from date of manufacture.

Special Precautions for Storage

No special precautions for storage.

Nature and Contents of Container

    Pack size
(a) polypropylene jars with polyethylene tamper-evident caps (1) 60
  (2) 125
  (3) 175
  (4) 250
  (5) 400
(b) polypropylene jar with propylene cap (1) 25
  (2) 15
(c) COEX HDPE:LDPE 70:30 plastic tube with flip top cap covered with a clear tamper evident plastic sleeve (1) 30

Special Precautions for Disposal and Other Handling

Not applicable.

Marketing Authorisation Holder

Forest Tosara Limited

Unit 146 Baldoyle Industrial Estate

Baldoyle

Dublin 13

Republic of Ireland

Marketing Authorisation Number(s)

PL 06166/0003

Date of First Authorisation/Renewal of the Authorisation

5 March 2004

Date of Revision of the Text

18/10/2013

Company contact details

Forest Laboratories UK Limited (a subsidiary of Actavis PLC)

http://www.actavis.co.uk

Address

Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Fax

+44 (0)1271 346106

Medical Information e-mail

medinfo@actavis.co.uk

Telephone

+44 (0)1271 311 200

Medical Information Direct Line

+44(0)1271 385 257