Coco-Scalp

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Coal tar solution 12% w/w;  ; Salicylic acid 2% w/w;  ; Sulfur 4% w/w;  
Available from:
AFT Pharmaceuticals Ltd
INN (International Name):
Coal tar solution 12% w/w
Dosage:
12%w/w, 2%w/w, 4%w/w
Pharmaceutical form:
Topical ointment
Composition:
Active: Coal tar solution 12% w/w   Salicylic acid 2% w/w   Sulfur 4% w/w   Excipient: Cetostearyl alcohol Coconut oil Glycerol Hard Paraffin Liquid paraffin Macrogol stearate 400 White soft paraffin
Units in package:
Tube, aluminium, intern. lacquer/polyuretha top, 40 g
Class:
General sale
Prescription type:
General sale
Manufactured by:
Frutarom USA Inc.
Product summary:
Package - Contents - Shelf Life: Tube, aluminium, intern. lacquer/polyuretha top - 25 g - 30 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Tube, aluminium, intern. lacquer/polyuretha top - 40 g - 30 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C
Authorization number:
TT50-7030
Authorization date:
2003-01-23

Coco-Scalp

Coal tar solution 12% w/w, Salicylic acid 2% w/w, Sulfur 4% w/w

Name of the medicinal product

Coco-Scalp (Coconut Oil Compound Ointment)

Qualitative and quantitative composition

Active ingredients

% w/w

Coal Tar Solution BP

12.0

Sulphur for External Use Ph.Eur

Salicylic Acid Ph.Eur

Pharmaceutical form

Ointment for topical application

Clinical particulars

Therapeutic indications

Coco-Scalp has mild, antipruritic, antiseptic and keratolytic properties. It is indicated

in the treatment of common scaly skin disorders of the scalp such as psoriasis,

eczema, seborrhoeic dermatitis and dandruff.

Posology and method of administration

Adults, children over 12 years and the elderly

Mild dandruff

To be used intermittently as an adjunctive treatment to be applied approximately

once a week.

Psoriasis, eczema, seborrhoeic dermatitis and severe dandruff

To be used daily for three to seven days until improvement has been achieved.

Intermittent repeated applications may be necessary to maintain improvement.

In all cases, the affected area should be treated and shampooed off using warm

water approximately one hour later.

Children 6 – 12 years

To be used under medical supervision only

Children under 6 years

Not recommended

Contra indications

This product is contraindicated in patients known to be sensitive to any of the

ingredients including sulphur and salicylates, coal tar, in the presence of acute local

infections or acute pustular psoriasis.

Special warnings and special precautions for use

Avoid contact with the eyes and wash hands immediately after

use. Discontinue use if irritation develops.

If symptoms persist after four weeks, consult your

doctor. Coal tar may stain bed linen and jewellery.

Interaction with other medicaments and other forms of interaction

None reported.

Use in pregnancy and lactation

To be used at the discretion of the physician.

Effects on ability to drive and use machinery

None

Undesirable effects

Coal Tar may cause skin irritation, folliculitis and rarely photosensitivity.

Overdose

Overdose is extremely unlikely. Treat symptomatically, if necessary.

Pharmacological properties

Pharmacodynamic properties.

Coal Tar is antipruritic, keratoplastic and a weak antiseptic.

Salicylic acid has keratolytic properties.

Sulphur is a keratolytic, with weak antiseptic and parasiticide properties.

Combinations of coal tar, salicylic acid and sulphur are widely used in the treatment

of hyperkeratotic and scaling skin conditions.

Pharmacokinetic properties

No data is available for the proposed formulation.

Preclinical safety data

None stated.

Pharmaceutical particulars

List of excipients

Coconut Oil BP

White Soft Paraffin BP

Cetostearyl Alcohol Ph. Eur.

Glycerol Ph. Eur.

Liquid Paraffin Ph. Eur.

Polyoxyethylene Glycerol Monostearate HSE

Hard Paraffin Ph. Eur.

Incompatibilities

None known

Shelf Life

30 months from date of manufacture (unopened) stored at or below 25

4 weeks opened stored at or below 25

Special precautions for storage

Store up to 25

C. Do not refrigerate.

Nature and contents of container

Coco -Scalp is packed into internally lacquered, membrane sealed, aluminium tubes

fitted with a polyurethane cap. The product is available in a pack size of 40g

Instructions for use/handling

None stated

Medicine classification

General Sales Medicine

Further information

Available in pack sizes:

25 g

40 g

Name and address of supplier

AFT Pharmaceuticals Ltd,

PO Box 33-203,

Takapuna, AUCKLAND

Email address: customer.service@aftpharm.com

Date of preparation

October 2014

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