Dermikelp® Itch Relief Cream

Available in 25g and 50g Tubes

Product Details

Dermikelp® Cream is clinically proven to soothe itchy irritated skin conditions and is suitable for eczema, contact dermatitis, seborrhoeic dermatitis, allergic reactions and minor insect bites.

The unique formulation is free of corticosteroids and other harmful additives, making it suitable for long term use and ideal for all ages. Dermikelp® Cream soothes naturally, while effectively relieving the itching, scratching and flaking symptoms of problem skin.

  • Free of Corticosteroids, Coal Tar & Parabens
  • Non-Greasy
  • Fragrance Free
  • Rapid relief from itching & scratching
  • Soothes inflamed skin conditions
  • Reduces dryness, moisturises dry skin
  • Improves skin healing time
  • Enhances skin condition
  • Reduces the chance of infection
DIRECTIONS FOR USE

Apply Dermikelp® Cream to the affected area as required. Gently rub the cream into the skin until it is completely absorbed. Repeat as required. When condition is controlled, continue to use daily as part of your regular skin maintenance program.

ACTIVE INGREDIENTS:

Each gram contains 375 mg of Ecklonia maxima extract.

  • Caprylyl glycol
  • Cetearyl alcohol
  • cetearyl glucoside
  • citric acid
  • ethylhexylglycerin
  • gluconolactone
  • isopropyl myristate
  • PEG-20 stearate
  • petrolatum
  • phenoxyethanol
  • sodium benzoate 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

PROPRIETRY NAME AND DOSAGE FORM

DERMIKELP® CREAM

COMPOSITION

Active ingredient:

Each gram contains 375 mg of Ecklonia maxima extract.
Inactive ingredients:

Caprylyl glycol, cetearyl alcohol, cetearyl glucoside, citric acid, ethylhexylglycerin, gluconolactone, isopropyl myristate, PEG-20 stearate, petrolatum, phenoxyethanol, sodium benzoate and water.

PHARMACOLOGICAL CLASSIFICATION

D 32.16 Other

PHARMACOLOGICAL ACTION

Pharmacodynamic properties
Ecklonia maxima is a member of the genus Eckloniaand contains a variety of compounds that play diverse biological and ecological roles.
The isolates from Ecklonia maximaare phloroglucinol, eckol, 7-phloroeckol and 2-phloroeckol.

Pharmacokinetic properties
Ecklonia species are utilized for therapeutic applications as they exhibit antioxidant andanti-inflammatory activities.

INDICATIONS

DERMIKELP® CREAM is clinically proven to soothe itchy irritated skin and is suitable for the symptoms associated with eczema, contact dermatitis, seborrhoeic dermatitis, minor insect bites and allergic skin reactions caused by soaps, detergents, cosmetics and jewellery.

CONTRA-INDICATIONS

Hyper sensitivity to Ecklonia maxima, iodine orany of the other ingredients in DERMIKELP® CREAM (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.
Apply to the affected area as required. Massage gently into the skin to ensure proper absorption.
DERMIKELP® CREAM can be used daily as required.

SIDE EFFECTS

See WARNINGS AND SPECIAL PRECAUTIONS.
Skin and subcutaneous tissue disorders:
Less frequent: Light erythema.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF TREATMENT

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

IDENTIFICATION

Off-white to beige cream with characteristic odour.

PRESENTATION

White, plastic tube packed into an outside carton.
Pack sizes: 25 g, 50 g and 100 g tubes.

STORAGE INSTRUCTIONS

Store at or below 25 ?.
Protect from sunlight.
Keep container tightly closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER

To be allocated by Council.

To be allocated by Council.

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE

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

DATE OF PUBLICATION OF PACKAGE INSERT

October 2014

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

Please read this leaflet carefully because it contains important information for you:

  • Keep this leaflet. You may need to read it again
  • Do not share DERMIKELP® CREAM with any other person.
  • Ask your pharmacist if you need more information or advice.
  • You must see a doctor if your symptoms worsen or do not improve after ten days.

1. WHAT DERMIKELP® CREAM CONTAINS

The active substance is Ecklonia maxima extract.
The other ingredients are caprylyl glycol, cetearyl alcohol, cetearyl glucoside, citric acid, ethylhexylglycerin, gluconolactone, isopropyl myristate, PEG-20 stearate, petrolatum, phenoxyethanol, sodium benzoate and water.

2. WHAT DERMIKELP® CREAM IS USED FOR

DERMIKELP® CREAM is clinically proven to soothe itchy irritated skin and is suitable for the symptoms associated with eczema (dry, inflamed irritated skin), contact dermatitis (skin rash after touching something), seborrhoeic dermatitis (scaling skin rash), minor insect bites and allergic skin reactions caused by soaps, detergents, cosmetics and jewellery.

3. BEFORE YOU USE DERMIKELP® CREAM

Do not use DERMIKELP® CREAM:
If you are hyper sensitive (allergic) to Ecklonia maxima, iodine or any of the other ingredients of DERMIKELP® CREAM (see WHAT DERMIKELP?CREAM CONTAINS).

Take special care with DERMIKELP® CREAM:
If you have broken skin areas. DERMIKELP® CREAM can cause a burning or stinging sensation when you apply it to broken skin.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, please consult your doctor, pharmacist or healthcare professional before taking DERMIKELP® CREAM.
Safety during pregnancy and breastfeeding has not been established.

Driving and using machinery:
No studies have been done to establish the safety of DERMIKELP® CREAM during driving a vehicle or operating machinery. Do not drive a vehicle, operate machinery, or do anything else that require your attention until your know how DERMIKELP® CREAM affects you.

Using other medicines with DERMIKELP® CREAM:
Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines).
Do not use DERMIKELP® CREAM in combination with other topical applications (such as creams or ointments) unless otherwise indicated by your healthcare professional.

4. HOW TO USE DERMIKELP® CREAM

For external use only.
Always use DERMIKELP® CREAM exactly as instructed. You should check with your doctor or pharmacist if you are unsure.
Apply to the affected area as required. Massage gently into your skin to ensure proper absorption.
DERMIKELP® CREAM can be used daily as required.
If you have the impression that the effect of DERMIKELP® CREAM is too strong or too weak, talk to your doctor or pharmacist.

If you use more DERMIKELP® CREAM than you should:
If you or your child accidentally ingested DERMIKELP?CREAM, 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 cream with you so the doctor will know what you have taken.

If you forget to use DERMIKELP® CREAM:
Apply daily as required.

5. POSSIBLE SIDE EFFECTS

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

If any of the following happens, stop using DERMIKELP® CREAM 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®CREAM. 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.

6. STORING AND DISPOSING OF DERMIKELP® CREAM

  • Store at or below 25?.
  • Keep closed. Protect from sunlight.
  • Do not remove from outer carton until required for use.
  • 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).

7. PRESENTATION OF DERMIKELP® CREAM

White, plastic tube packed into an outside carton.
Pack sizes: 25 g, 50 g and 100 g tube.

8. IDENTIFICATION OF DERMIKELP® CREAM

Off-white to beige cream with characteristic odour.

9. REGISTRATION NUMBER

To be allocated by Council.

10. NAME AND ADDRESS OF THE REGISTRATION HOLDER

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

11. DATE OF PUBLICATION

October 2014

Dermikelp® Skin Cream
Dermikelp® Skin Spray
Dermikelp® Moisturising Lotion
Dermikelp® Body Wash