For the use only of Registered Medical Practitioners or a Hospital or a Laboratory

EMODERM CREAM

White Soft Paraffin Cream

QUALITATIVE AND QUANTITATIVE COMPOSITION

Emollient Cream base containing Benzoic Acid I.P. 0.2% w/w

(as preservative)

PHARMACEUTICAL FORM

Cream.

CLINICAL PARTICULARS

Therapeutic Indications

Treatment of dry skin conditions including eczema, ichthyosis and pruritus of the elderly.

Posology and Method of Administration

For topical use only. May be used as frequently as necessary.

Adults, adolescents and children

Apply to the skin as required and smooth into the skin in the direction of hair growth.

Elderly

No dosage adjustment is necessary.

Renal impairment

No dosage adjustment is necessary.

Hepatic impairment

No dosage adjustment is necessary.

Contraindications

Hypersensitivity to any of the ingredients.

Special Warnings and Special Precautions for Use

For external use only. Keep out of reach of children. Guard against slipping. Discontinue use
if the condition is made worse. Do not apply to broken skin.

1
Patients being dispensed or treated with large quantities (> 100g) of any paraffin based product
should be advised to regularly change clothing or bedding impregnated with the product and
keep away from naked flames as there is a fire hazard.

Interaction with Other Medicaments and Other Forms of Interaction

None identified.

Pregnancy and Lactation

Fertility

No data available on the use of EMODERM Cream on human fertility.

Pregnancy

Can be used.

Lactation

Can be used.

Effects on Ability to Drive and Use Machines

Not relevant.

Undesirable Effects

May cause contact dermatitis.

Overdose

Symptoms and signs

The product is intended for topical use only. Accidental ingestion may cause gastrointestinal
irritation with nausea, vomiting and diarrhoea.

Treatment

In case of ingestion, management should be as clinically indicated or as recommended by the

national poisons centre, where available.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic Properties

Pharmacotherapeutic Group: Dermatologicals, other emollients and protectives; ATC code :

D02AX

Pharmacodynamic Effects

2
Emollients are fats or oils used for their local action on the skin and, occasionally, the mucous
membranes. These oleaginous substances, also known as occlusive agents and humectants, are
employed as protectives and as agents for softening the skin and rendering it more pliable.
White soft paraffin forms an effective occlusive lipid film. The mechanism of action is by
occluding water loss from the outer layer of skin.

Pharmacokinetic Properties

White soft paraffin exerts its physiological effects by forming an occlusive layer on the surface
of the skin. It is effective because it is not subject to absorption or subsequent distribution in
the body, excretion or metabolism. Pharmacokinetic particulars are not appropriate in these
circumstances.

Preclinical Safety Data

No relevant pre-clinical data has been generated.

PHARMACEUTICAL PARTICULARS

List of Excipients

White Soft Paraffin, Stearyl Alcohol, Cetyl Alcohol, Polysorbate 60, Isopropyl Myristate,
Propylene Glycol, Benzoic Acid, Glycerin, Perfume Compound FL, Purified water.

Incompatibilities

No incompatibilities have been identified.

Shelf Life

The expiry date is indicated on the label and packaging.

Special Precautions for Storage

Store in a cool place, at a temperature not exceeding 25oC. Do not freeze.

Keep out of reach of children.

Nature and Specification of Container

Tube in a carton

Instructions for Use / Handling

For external use only.

There are no other special requirements for use or handling of this product.

For further information please contact:

3
GlaxoSmithKline Pharmaceuticals Limited.
Registered Office
Dr. Annie Besant Road, Worli
Mumbai 400 030, India.

Trade marks are owned by or licensed to the GSK group of companies

Version EMO/PI/IN/2018/01 dated 01 March 2018

Adapted from :
• Dermamist SPC (updated on eMC 27-Mar-2015, date of revision of the text 3rd
February 2015).
• White soft paraffin-light liquid paraffin GDS Version 01 dated 24 September 2012.