ACTIVE INGREDIENT:

Each ml contains 130 mg of Ecklonia maxima extract.

INACTIVE INGREDIENTS:

Acrylates/C10-30 alkyl acrylate crosspolymer, citric acid, cocamidopropyl betaine, ethylene/sodium acrylate crosspolymer, methylisothiazolinone (and) decylene glycol, parfum, polysorbate-20, sodium benzoate, sodium laurylether sulphate, triethanolamine and water.

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^® BODY WASH

COMPOSITION

Active ingredient:

Each ml contains 130 mg of Ecklonia maxima extract.

Inactive ingredients:

Acrylates/C10-30 alkyl acrylate crosspolymer, citric acid, cocamidopropyl betaine, ethylene/sodium
acrylate crosspolymer, methylisothiazolinone (and) decylene glycol, parfum, polysorbate-20,
sodium benzoate, sodium laurylether sulphate, triethanolamine and water.

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 antiinflammatory
activities.

INDICATIONS

DERMIKELP^® BODY WASH assists with the symptoms associated with:

• Eczema
• Psoriasis
• Dermatitis

ACTIONS

• Relieves itch & irritation
• Soothes
• Cleanses
• Refreshes

CLINICALLY TESTED

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

IDEAL FOR EVERYDAY USE FOR THE WHOLE FAMILY

• Squeeze a generous amount onto a washcloth, sponge or palm of your hand
• Lather over entire body
• Rinse well
• If product gets into eyes, wash thoroughly with water

FOR BEST RESULTS

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

CONTRAINDICATIONS

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

WARNINGS AND SPECIAL PRECAUTIONS

A stinging or burning sensation may be felt when applied to broken skin.

Effects on ability to drive and use machines:

No studies have been done to establish the effects on the ability to drive a vehicle or operate
machinery.

INTERACTIONS

Do not use in combination with other topical 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.

Squeeze a generous amount onto a washcloth, sponge or palm of hand and lather over the body.

Rinse well. Can be used daily to clean and soothe irritated and itchy skin.

If DERMIKELP?BODY WASH gets into the eyes, wash thoroughly with water.

SIDE EFFECTS

Skin and subcutaneous tissue disorders:

Less frequent: Light erythema.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT

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

IDENTIFICATION

A beige to light brown body wash with characteristic odour.

PRESENTATION

White HDPE container with snap cap, packed into a printed outer carton.

Pack size: 250 ml.

STORAGE INSTRUCTIONS

Store at or below 25 ?.
Protect from sunlight.
Keep container closed.

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER

To be allocated by Council.

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

August 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 S0

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM

DERMIKELP^® BODY WASH

Read all of this leaflet carefully because it contains important information for you:
DERMIKELP^® BODY WASH is available without a doctor? prescription. Nevertheless you
still need to use DERMIKELP^® BODY WASH 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^® BODY WASH CONTAINS

Each ml contains 130 mg of Ecklonia maxima extract as active substance.

The other ingredients are acrylates/C10-30 alkyl acrylate crosspolymer, citric acid,
cocamidopropyl betaine, ethylene/sodium acrylate crosspolymer, methylisothiazolinone (and)
decylene glycol, parfum, polysorbate-20, sodium benzoate, sodium laurylether sulphate,
triethanolamine and water.

WHAT DERMIKELP^® BODY WASH IS USED FOR

DERMIKELP^® BODY WASH is used to assist in relieving the symptoms associated with
eczema, psoriasis and dermatitis. Can be used daily to clean and soothe irritated and itchy
skin.

BEFORE YOU USE DERMIKELP^® BODY WASH

Do not use DERMIKELP^® BODY WASH:

If you are hypersensitive (allergic) to Ecklonia maxima, iodine or any of the other ingredients
of DERMIKELP^® BODY WASH (see WHAT DERMIKELP^® BODY WASH CONTAINS).

Take special care with DERMIKELP^® BODY WASH:

If you have broken skin areas. DERMIKELP^® BODY WASH can cause a burning or stinging
sensation when you use it on broken skin.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, please consult your doctor, pharmacist or healthcare
professional before using DERMIKELP^® BODY WASH.
Safety during pregnancy and breastfeeding has not been established.

Driving and using machinery:

No studies have been done to establish the effect of DERMIKELP^® BODY WASH on your
ability to drive a vehicle or operate machinery. Do not drive a vehicle, operate machinery, or
do anything else that require your attention until you know how DERMIKELP^® BODY WASH
affects you.

Using other medicines with DERMIKELP^® BODY WASH:

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

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

HOW TO USE DERMIKELP?BODY WASH

For external use only.

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

Squeeze a generous amount onto a washcloth, sponge or palm of hand and lather over your
body. Rinse well. Can be used daily to clean and soothe irritated and itchy skin.

If DERMIKELP^® BODY WASH gets into the eyes, wash thoroughly with water.

If you have the impression that the effect of DERMIKELP^® BODY WASH is too strong or too
weak, talk to your doctor or pharmacist.

If you use more DERMIKELP^® BODY WASH than you should:

If you or your child accidentally ingested DERMIKELP^® BODY WASH, consult your doctor
or pharmacist. If neither is available, contact the nearest hospital or poison centre.
Take this leaflet and the container with the remaining body wash with you so the doctor will
know what has been taken.

If you forget to use DERMIKELP^® BODY WASH:

Use daily as required.

POSSIBLE SIDE EFFECTS

DERMIKELP^® BODY WASH can have side effects.

Not all side effects reported for DERMIKELP^® BODY WASH are included in this leaflet.

Should your general health worsen or if you experience any untoward effects while
using DERMIKELP^® BODY WASH, please consult your doctor, pharmacist or other
healthcare professional for advice.

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

• Swelling of your hands, feet, ankles, face, 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^® BODY WASH. You may need urgent medical attention or
hospitalisation.

Tell your doctor 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^® BODY WASH

• Store at or below 25 ?.
• Protect from sunlight.
• Keep container closed.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the label or carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

PRESENTATION OF DERMIKELP^® BODY WASH

White HDPE container with snap cap, packed into a printed outer carton.
Pack size: 250 ml.

IDENTIFICATION OF DERMIKELP^® BODY WASH

A beige to light brown body wash with characteristic odour.

REGISTRATION NUMBER

To be allocated by Council.

NAME AND ADDRESS OF THE REGISTRATION HOLDER

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

DATE OF PUBLICATION

August 2015