This site is intended for healthcare professionals
Blue, green and purple abstract wave
Drug information

Sudocrem

OTC
Read time: 2 mins
Last updated: 10 Sep 2019
...
 

Summary of product characteristics


1. Name of the medicinal product

Sudocrem Antiseptic Healing Cream


2. Qualitative and quantitative composition

% w/w

Zinc oxide

15.25

Benzyl alcohol

0.39

Benzyl benzoate

1.01

Benzyl cinnamate

0.15

Lanolin (hypoallergenic)

4.00


3. Pharmaceutical form

Emulsified water in oil cream


4.1. 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


4.2. 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.


4.3. Contraindications

Hypersensitivity to any of the ingredients.


4.4. 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.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.


4.5. Interaction with other medicinal products and other forms of interaction

None known.


4.6. Fertility, pregnancy and lactation

There are no known contraindications.


4.7. Effects on ability to drive and use machines

Not applicable.


4.8. Undesirable effects

Side effects include local hypersensitivity occasionally.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.


4.9. Overdose

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


5.1. 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 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.


5.2. Pharmacokinetic properties

Not applicable.


5.3. Preclinical safety data

Not applicable.


6.1. List of excipients

Purified Water

Sodium Benzoate

Paraffin wax

Microcrystalline wax

Heavy Liquid Paraffin

Synthetic Beeswax

Sorbitan sesquioleate

Propylene glycol

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

Linalyl acetate

Lavender


6.2. Incompatibilities

None known.


6.3. Shelf life

Not exceeding 3 years from date of manufacture.


6.4. Special precautions for storage

No special precautions for storage.


6.5. 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


6.6. Special precautions for disposal and other handling

Not applicable.


7. Marketing authorisation holder

Teva UK Limited,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex

BN22 9AG,

United Kingdom


8. Marketing authorisation number(s)

PL 00289/2299


9. Date of first authorisation/renewal of the authorisation

5 March 2004


10. Date of revision of the text

30/08/2019

4.1 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

4.2 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.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 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.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

There are no known contraindications.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Side effects include local hypersensitivity occasionally.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Drug section

A close up image of a microscope
Clinical trial
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis (ESTEEM 1)

This study evaluated the effects of an called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis.

2 mins
Clinical trial
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis (GESTURE)

To demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess long term efficacy, safety and tolerability of secukinumab.

4 min
Clinical trial
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis. (ESTEEM 2)

This study will evaluate the effects of an experimental (being tested) study drug called apremilast.

2 min
Journals
Journal
Deroofing: a tissue-saving surgical technique for the treatment of mild to moderate hidradenitis suppurativa lesions

Objective: We sought to evaluate the efficacy and patient satisfaction of the deroofing technique for recurrent Hurley I (mild) or II (moderate) graded HS lesions at fixed locations.

1 mins
Journal
Candida infections in psoriasis and psoriatic arthritis patients treated with IL-17 inhibitors and their practical management

<p>The recognition of the central role of interleukin 17A (IL-17A) in the pathogenesis of psoriasis has led to the development of several monoclonal antibodies targeting this cytokine or its receptors for therapeutic purposes.</p>

1 min
Journal
Morbidity in patients with hidradenitis suppurativa

Objectives: To measure the impairment of life quality in patients with HS.

1 min
CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

 

 

Disclaimer

The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.

Medthority will not be held liable for explicit or implicit errors, or missing data.

Reporting of suspected adverse reactions 

Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).