ACTIVE INGREDIENT:

Each ml contains 100 mg of Ecklonia maxima (sea kelp) extract.

INACTIVE INGREDIENTS:

Propane, butane, aqua, propylene glycol, Cananga odorata (Ylang Ylang) flower oil, acetic acid, hydrogen peroxide.

This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.

SCHEDULING STATUS

S0

PROPRIETARY NAME AND DOSAGE FORM

DERMIKELP^® SKIN SPRAY

COMPOSITION

Active ingredient:

Each ml contains 100 mg of Ecklonia maxima extract.

Inactive ingredients:

Propane, butane, aqua, propylene glycol, Cananga odorata (Ylang Ylang) flower oil, acetic acid, hydrogen peroxide.

PHARMACOLOGICAL CLASSIFICATION

D 32.16 Other

PHARMACOLOGICAL ACTION

Pharmacodynamic properties

Ecklonia maxima is a member of the genus Ecklonia and contains a variety of compounds that play diverse biological and ecological roles.

The isolates from Ecklonia maxima are phloroglucinol, eckol, 7-phloroeckol and 2-phloroeckol.

Pharmacokinetic properties

Ecklonia species are utilised for therapeutic applications as they exhibit antioxidant and anti-inflammatory activities.

INDICATIONS

DERMIKELP^® SKIN SPRAY assists in soothing itchy and irritated skin, also associated with eczema, psoriasis and dermatitis.

• Eczema
• Dermatitis
• Psoriasis

ACTIONS

• Relieves itch & irritation

CLINICALLY TESTED

• Clinically proven active ingedient ?CEM-K?(Ecklonia maxima or sea kelp extract)
• Dermatologically tested
• For all skin types
• For all ages

IDEAL FOR EVERYDAY USE FOR THE WHOLE FAMILY

• Shake well before use
• Hold 15cm from body and spray onto affected area
• Repeat as required

FOR BEST RESULTS

• Use in combination with Dermikelp^® Moisturising Lotion & Dermikelp^® Itch Relief Cream

CONTRAINDICATIONS

Hypersensitivity to Ecklonia maxima, iodine or any of the other ingredients of DERMIKELP^® SKIN SPRAY (see COMPOSITION).

WARNINGS AND SPECIAL PRECAUTIONS

• FOR EXTERNAL USE ONLY.
• Keep the mouth and eyes closed during spraying. Avoid contact with mucosa and eyes.
• Do not inhale or swallow aerosol gases.
• Avoid application to broken skin. A stinging sensation may be experienced if applied to broken skin.
• Spray brief puffs without prolonged spraying.
• Use and store DERMIKELP^® SKIN SPRAY away from any naked flame or heat source.
• Spray DERMIKELP^® SKIN SPRAY in a well ventilated room and air well after use.
• Do not smoke during or shortly after spraying DERMIKELP^® SKIN SPRAY.

Effects on ability to drive and use machines:

The effect of DERMIKELP^® SKIN SPRAY on the ability to drive a vehicle and use machines has not been studied.

INTERACTIONS

Do not use in combination with other topical skin applications unless otherwise indicated by a healthcare professional.

PREGNANCY AND LACTATION

Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE

• For external use only.
• Shake well before use.
• Hold 15 cm from body and spray onto the affected area. Repeat as required.
• Rinse thoroughly with water if DERMIKELP^® SKIN SPRAY gets into the eyes.

SIDE EFFECTS

Skin and subcutaneous tissue disorders:

Less frequent: Light erythema.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

DERMIKELP^® SKIN SPRAY is indicated for external use only. In the event of accidental ingestion, treatment should be symptomatic and supportive.

IDENTIFICATION

Clear to amber coloured liquid.

PRESENTATION

An aluminium aerosol can with white actuator and white cap, packed into a printed outer carton.

Pack size: 90 ml.

STORAGE INSTRUCTIONS

• Store at or below 25 ?.
• Protect from sunlight.
• Store away from any naked flame or heat source.
• The aerosol container is conditioned under pressure.

Do not pierce or throw into fire even when empty.

• KEEP OUT OF REACH OF CHILDREN.

 

REGISTRATION NUMBER

Will be allocated by Council upon registration.

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION

Lamicare SA (Pty) Ltd.
Unit 56, Frazzitta Business Park
1 Freedom Way
Milnerton
7441

DATE OF PUBLICATION OF THE PACKAGE INSERT

September 2015.

This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.

SCHEDULING STATUS

Schedule 0

PROPRIETARY NAME AND DOSAGE FORM

DERMIKELP?SKIN SPRAY

Read all of this leaflet carefully because it contains important information for you:
DERMIKELP^® SKIN SPRAY is available without a doctor? prescription. Nevertheless you still need to useDERMIKELP^®SKIN SPRAY carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must see a doctor if your symptoms worsen or do not improve.

WHAT DERMIKELP^® SKIN SPRAY CONTAINS

Each ml contains 100 mg of Ecklonia maxima extract as active substance.
The other ingredients are propane, butane, aqua, propylene glycol, Cananga odorata (Ylang Ylang) flower oil, acetic acid, hydrogen peroxide.

WHAT DERMIKELP^® SKIN SPRAY IS USED FOR

DERMIKELP^® SKIN SPRAY is used to assist in soothing itchy and irritated skin, also associated with eczema (inflamed patches of the skin), psoriasis (red, itchy and scaly patches of the skin) and dermatitis (red, swollen and sore patches of the skin).

BEFORE YOU USE DERMIKELP^® SKIN SPRAY

Do not use DERMIKELP^® SKIN SPRAY:

If you are hypersensitive (allergic) to Ecklonia maxima, iodine or any of the other ingredients of DERMIKELP?SKIN SPRAY (see WHAT DERMIKELP?SKIN SPRAY CONTAINS).

Take special care with DERMIKELP^® SKIN SPRAY:

• Keep your mouth and eyes closed during spraying. Avoid contact with mucosa and eyes.
• Do not inhale or swallow aerosol gases.
• If you have broken skin areas. DERMIKELP^® SKIN SPRAY can cause a burning or stinging sensation when you use it on broken skin.
• Use and store DERMIKELP^® SKIN SPRAY away from any naked flame or heat source.
• Spray DERMIKELP^® SKIN SPRAY in a well ventilated room and air well after use.
• Do not smoke during or shortly after spraying DERMIKELP^® SKIN SPRAY.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking DERMIKELP^® SKIN SPRAY.

Driving and using machinery:

The effect of DERMIKELP^® SKIN SPRAY on the ability to drive a vehicle and use machines have not been studied. Do not drive a vehicle, operate machinery, or do anything else that requires your attention until you know how DERMIKELP^® SKIN SPRAY affects you.

Using other medicines with DERMIKELP^® SKIN SPRAY:

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)

Do not use DERMIKELP^® SKIN SPRAY in combination with other topical applications (such as shampoos, creams or ointments) unless otherwise indicated by your healthcare professional.

HOW TO USE DERMIKELP^® SKIN SPRAY

Always use DERMIKELP^® SKIN SPRAY exactly as instructed. You should check with your doctor or pharmacist if you are unsure.

FOR EXTERNAL USE ONLY.

Shake well before use.

Hold 15 cm from your body and spray DERMIKELP^® SKIN SPRAY onto the affected area. Repeat as required.

If you have the impression that the effect of DERMIKELP^® SKIN SPRAY is too strong or too weak, tell your doctor or pharmacist.

If you use more DERMIKELP^® SKIN SPRAY than you should:

• If you or your child accidentally ingested DERMIKELP^® SKIN SPRAY, consult your doctor or pharmacist.
• If neither is available contact the nearest hospital or poison centre.
• Take this leaflet and the rest of the remaining skin spray with you so the doctor will know what you have used.

If you forget to use DERMIKELP^® SKIN SPRAY:

Use as required.

POSSIBLE SIDE EFFECTS

DERMIKELP^® SKIN SPRAY can have side effects.

Not all side effects reported for DERMIKELP^® SKIN SPRAY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using DERMIKELP^® SKIN SPRAY, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using DERMIKELP^® SKIN SPRAY and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DERMIKELP^®SKIN SPRAY. You may need urgent medical attention or hospitalisation.

Tell your doctor as soon as possible if you notice any of the following:

• Slight redness of your skin.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

STORING AND DISPOSING OF DERMIKELP^® SKIN SPRAY

• Store at or below 25 ?.
• Protect from sunlight.
• Store away from any naked flame or heat source.
• The aerosol container is conditioned under pressure.
• Do not pierce or throw into fire even when empty.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the container.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

PRESENTATION OF DERMIKELP^® SKIN SPRAY

An aluminium aerosol can with white actuator and white cap, packed into a printed outer carton.

Pack size: 90 ml.

IDENTIFICATION OF DERMIKELP^® SKIN SPRAY

Clear to amber coloured liquid.

REGISTRATION NUMBER

Will be allocated by Council upon registration.

NAME AND ADDRESS OF REGISTRATION HOLDER

Lamicare SA (Pty) Ltd.
Unit 56, Frazzitta Business Park
1 Freedom Way
Milnerton 7441
Tel: 086 100 0400

DATE OF PUBLICATION

September 2015.