E 45 Cream

E 45 Cream

2. Qualitative and quantitative composition
Anhydrous Lanolin

1.0%

w/w

White Soft Paraffin

BP

14.5%

w/w

Light Liquid Paraffin

PhEur

12.6%

w/w

Excipient(s) with identified effect:

Cetyl alcohol

Methyl hydroxybenzoate (E218)

Propyl hydroxybenzoate (E216)

For the complete list of excipients, see section six.1

3. Pharmaceutical type
A cream

Smooth cream, white or much white with a small odour.

4. Clinical particulars
4.1 Therapeutic indications
For the symptomatic relief of dry skin conditions, wherever the utilization of AN emollient is indicated, like flaking, unsmooth skin, ichthyosis, traumatic eczema, sunburn, the dry stage of skin condition and sure dry cases of skin problem.

4.2 pharmacology and methodology of administration
Posology

Adults, the aged, kids and infants over the age of one month - apply to the affected half 2 or thrice daily.

Method of administration

For topical administration.

4.3 Contraindications
Hypersensitivity to white soft paraffin, lightweight liquid paraffin and anhydrous lanolin or to any of the excipients listed in section six.1.

4.4 Special warnings and precautions to be used
If rash develops, use of the merchandise ought to be discontinued .

Patients being distributed or treated with massive quantities (> 100g) of any paraffin- based mostly product ought to be suggested to frequently modification vesture, bedding or dressings inseminated with the merchandise and keep from naked flames as there's a fireplace hazard.

4.5 Interaction with different medicative product and different varieties of interaction
The absorption of topical Loniten may be inflated by synchronal topical soft paraffin. this might heighten the hypotensive effects of vasodilators

4.6 Fertility, gestation and lactation
Pregnancy

No effects throughout gestation area unit anticipated, since general exposure to white soft paraffin, liquid paraffin and lanolin is negligible. like all medicines, this product ought to be used with caution throughout gestation.

Breast-feeding

It is unknown whether or not soft paraffin, lightweight liquid paraffin and anhydrous lanolin metabolites area unit excreted in human milk. A risk to the newborns/ infants can not be excluded. Application of the merchandise to the breast isn't counseled throughout nursing.

Fertility

No knowledge on human fertility area unit obtainable.

4.7 Effects on ability to drive and use machines
The product has no or negligible influence on the flexibility to drive and use machines

4.8 Undesirable effects
Occasionally, hypersensitivity reactions, otherwise adverse effects area unit unlikely. ought to this occur, use of the merchandise ought to be discontinued .

Adverse events that are related to white soft paraffin, lightweight liquid paraffin and anhydrous lanolin area unit given below, tabulated by system organ category and frequency. Frequencies area unit outlined as: quite common (≥1/10); Common (≥1/100 and

----------------------------------------------------------------------------------------------------------------

Labels :