Otodex Skin Cream

Composition

Active substance(s)

Chlorocresol 0.500% w/w

Phenoxyethanol 0.720% w/w

(constituent of Phenonip preservative, see below)

Zinc Oxide 9.000% w/w

Lidocaine Hydrochloride 0.050% w/w

Excipients

Quinoline Yellow dye 0.005% w/w

Phenonip (preservative) 1.000% w/w

(comprising 0.720% w/w phenoxyethanol (above) and 0.28%w/w mixed hydroxybenzoate esters)

For a full list of excipients, see section 6.1.

6.1 List of excipients

Phenonip - consists of: 2-Phenoxyethanol >60%

Methyl-4-hydroxybenzoate 15-30%

Ethyl-4-hydroxybenzoate <5%

Butyl-4-hydroxybenzoate <5%

Isobutyl-4-hydroxybenzoate <5%

Propyl-4-hydroxybenzoate <5%

Quinoline yellow

Liquid paraffin

White beeswax

White soft paraffin

Hard paraffin

Wool alcohols

Borax

Sorbitan monoisostearate

Fern DH192

Water potable

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Pharmaceutical form

Cream.

Pale yellow, oily cream with the odour of fern for topical application.

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Pharmacological properties

Pharmacotherapeutic group: Phenol and derivatives, combinations

ATCvet code: QD08AE99

5.1 Pharmacodynamic properties

Chlorocresol is a powerful phenolic disinfectant with lower toxicity than phenol but known CNS stimulant properties in cats, which also aids in the presentation of the product. Phenoxyethanol is a bactericide particularly effective against Pseudomonas aeruginosa and can be used topically in the treatment of bacterial infections. Zinc oxide is applied externally as a mild astringent for the skin, as a soothing and protective application in eczema, and as a protective to slight excoriations. Lidocaine hydrochloride is a local anaesthetic which has an analgesic function in the formulation.

5.2 Pharmacokinetic particulars

Not stated.

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Target species

Cats and Dogs.

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Indications

As an aid in the treatment of eczema, sore spots, abrasions and minor burns.

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Dosage

Clean wound, carefully remove over-lying hair from affected parts and lightly apply the cream at night and in the morning.

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Contraindications

None.

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Adverse reactions

Cats are particularly susceptible to CNS effect, of phenols, including vomiting, in coordination, depression and coma. When Chlorocresol has been absorbed systemically treatment should be symptomatic.

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Warnings

i) Special precautions for use in animals

For external use only. Use sparingly in cases where large areas of skin are damaged or affected.

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after use. In the event of accidental eye contact wash immediately with copious amounts of water. If the skin or eye irritation persists – seek medical attention showing the product label to the doctor.

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Use during pregnancy, lactation or lay

Not contraindicated during pregnancy but should not be used during lactation.

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Interactions

Contact with non-ionic surfactants may reduce the activity of certain phenols.

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Overdose

See 4.6 above.

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Special warnings

None.

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Withdrawal period

Not applicable

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Incompatibilities

None known.

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Immediate packaging

35g Containers; collapsible aluminium epoxy phenol internally lacquered tube; 11mm membrane nozzle fitted with a white polypropylene screw fit cap.

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Storage

Do not store above 25°C. Do not use if tube seal is broken when purchased.

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Shelf life

Shelf life of veterinary medicinal product as packaged for sale: 3 years

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Disposal of unused product

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

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Additional information

Vm 52797/5012

9 DATE OF FIRST AUTHORISATION

04 October 1995

10 DATE OF REVISION OF THE TEXT

January 2025

Approved 26 January 2025

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Registration holder

Pets Choice Limited

Brentwood House, Lower Philips Road

Whitebirk Industrial Estate

Blackburn

BB1 5UD

United Kingdom

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