Home | About the eMC | Help | Mobile

eMC - trusted, up to date and comprehensive information about medicines

Search medicine/company name only

Search full document

Medicine name A-Z | Active ingredient A-Z | Pharmaceutical company A-Z | Latest medicine updates | Yellow card report

Stiefel
Stockley Park West, , Uxbridge, Middlesex, UB11 1BT , UK Telephone: +44 (0)800 221 441 Fax: +44 (0)208 990 4328 Medical Information e-mail: customercontactuk@gsk.com Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 22/12/2010

SPC	Oilatum Emollient

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Oilatum Bath Formula

Oilatum Emollient

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Light Liquid Paraffin 63.4% w/w

Go to top of the page

3. PHARMACEUTICAL FORM

Liquid Bath Additive

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

Oilatum Emollient is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions. Oilatum Emollient replaces oil and water and hydrates the keratin. Oilatum Emollient is particularly suitable for infant bathing. The preparation also overcomes the problem of cleansing the skin in conditions where the use of soaps, soap substitutes and colloid or oatmeal baths proves irritating.

Go to top of the page

4.2 Posology and method of administration

Oilatum Emollient should always be used with water, either added to the water or applied to wet skin.

Adult bath:

Add 1-3 capfuls to an 8-inch bath of water, soak for 10-20 minutes. Pat dry.

Infant bath:

Add ½-2 capfuls to a basin of water, Apply gently over entire body with a sponge. Pat dry.

Skin cleansing:

Rub a small amount of oil into wet skin. Rinse and pat dry.

Where conditions permit, and particularly in cases of extensive areas of dry skin, Oilatum Emollient should be used as a bath oil, ensuring complete coverage by immersion. In addition to the therapeutic benefits, this method of use provides a means of sedating tense patients, particularly relevant in cases of acute pruritic dermatoses where relaxation of tension appears to relieve symptoms.

The product is suitable for use in adults, children and the elderly.

Go to top of the page

4.3 Contraindications

None

Go to top of the page

4.4 Special warnings and precautions for use

The patient should be advised to use care to avoid slipping in the bath. If a rash or skin irritation occurs, stop using the product and consult your doctor.

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

None known

Go to top of the page

4.6 Pregnancy and lactation

There is no, or inadequate, evidence of the safety of Oilatum Emollient in human pregnancy or lactation, but it has been in wide use for many years without ill consequence.

Go to top of the page

4.7 Effects on ability to drive and use machines

None

Go to top of the page

4.8 Undesirable effects

None

Go to top of the page

4.9 Overdose

Not applicable

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

5.1 Pharmacodynamic properties

Light liquid paraffin exerts an emollient effect by forming an occlusive oil film on the stratum corneum. This prevents excessive evaporation of water from the skin surface and aids in the prevention of dryness.

Go to top of the page

5.2 Pharmacokinetic properties

Not applicable

Go to top of the page

5.3 Preclinical safety data

Not applicable

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients

Acetylated Lanolin Alcohols

Isopropyl Palmitate