Dermikelp® Itch Relief Shampoo

Dermikelp® Itch Relief Shampoo contains the same clinically proven active ingredient found in Dermikelp® Cream to actively reduce inflammation of the scalp and relieve the itch associated with seborrhoeic dermatitis, dandruff and other irritated scalp conditions.

Available in 250ml bottle

Product Details

Dermikelp® Itch Relief Shampoo contains the same clinically proven active ingredient found in Dermikelp® Cream to actively reduce inflammation of the scalp and relieve the itch associated with seborrhoeic dermatitis, dandruff and other irritated scalp conditions.

Dermikelp® Itch Relief Shampoo has been dermatologically tested and can be used daily to improve the appearance and condition of the hair and scalp. It is also cortisone, coal tar and paraben free and is suitable for all ages.

  • Assists with the symptoms associated with a dry, itchy or irritated scalp
  • Suitable for daily use
  • Suitable for all ages
DIRECTIONS FOR USE

Wet hair, apply Dermikelp® Itch Relief Shampoo and gently massage into the scalp. Rinse and repeat as required.

ACTIVE INGREDIENT:

Each gram contains 31,5 mg of Ecklonia maxima extract.

INACTIVE INGREDIENTS:

Acrylates/C10-30 alkyl acrylate crosspolymer, caprylyl glycol, citric acid, cocamide DEA, gluconolactone, parfum, phenoxyethanol, polysorbate 20, polyquartenium 10, potassium sorbate, sodium benzoate, sodium laureth 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, STRENGTH AND PHARMACEUTICAL FORM

DERMIKELP® ITCH RELIEF SHAMPOO

COMPOSITIONM

Active ingredient:

Each gram contains 31,5 mg of Ecklonia maxima extract.

Inactive ingredients:

Acrylates/C10-30 alkyl acrylate crosspolymer, caprylyl glycol, citric acid, cocamide DEA, gluconolactone, parfum, phenoxyethanol, polysorbate 20, polyquartenium 10, potassium sorbate, sodium benzoate, sodium laureth sulphate, triethanolamine 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 diversebiological 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® ITCH RELIEF SHAMPOO assists in relieving dry, itchy and inflamed scalp conditions and reduces skin irritation.

CONTRAINDICATIONS

Hyper sensitivity to Ecklonia maxima, iodine or any of the other ingredients in DERMIKELP® ITCH RELIEF SHAMPOO (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.
  • Wet hair and apply DERMIKELP® ITCH RELIEF SHAMPOO. Gently massage into the scalp.
  • Rinse and repeat as required.

SIDE EFFECTS

Skin and subcutaneous tissue disorders:

  • Less frequent: Light erythema.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT

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

IDENTIFICATION

Off-white to beige shampoo with characteristic odour.

PRESENTATION

White, plastic bottle packed into an outside carton.>br>
Pack size: 250 ml.

STORAGE INSTRUCTIONS

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

REGISTRATION NUMBERS

To be allocated by Council.

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

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

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM

DERMIKELP® ITCH RELIEF SHAMPOO

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® ITCH RELIEF SHAMPOO 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.

WHAT DERMIKELP® ITCH RELIEF SHAMPOO CONTAINS

The active substance is Ecklonia maxima extract.

The other ingredients are acrylates/C10-30 alkyl acrylate crosspolymer, caprylyl glycol, citric acid, cocamide DEA, gluconolactone, parfum, phenoxyethanol, polysorbate 20, polyquartenium 10, potassium sorbate, sodium benzoate, sodium laureth sulphate, triethanolamine and water.

WHAT DERMIKELP® ITCH RELIEF SHAMPOO IS USED FOR

DERMIKELP® ITCH RELIEF SHAMPOO is used to assist in relieving dry, itchy and inflamed conditions on your scalp and reduces skin irritation.

BEFORE YOU USE DERMIKELP® ITCH RELIEF SHAMPOO

Do not use DERMIKELP® ITCH RELIEF SHAMPOO:

If you are hyper sensitive (allergic) to Ecklonia maxima, iodine or any of the other ingredients of DERMIKELP® ITCH RELIEF SHAMPOO (see WHAT DERMIKELP® ITCH RELIEF SHAMPOO CONTAINS).

Take special care with DERMIKELP® ITCH RELIEF SHAMPOO:

If you have broken skin areas. DERMIKELP® ITCH RELIEF SHAMPOO 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 taking DERMIKELP® ITCH RELIEF SHAMPOO.

Safety during pregnancy and breastfeeding has not been established.

Driving and using machinery:

No studies have been done to establish the safety of DERMIKELP® ITCH RELIEF SHAMPOO 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® ITCH RELIEF SHAMPOO affects you.

Using other medicines with DERMIKELP® ITCH RELIEF SHAMPOO:

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

HOW TO USE DERMIKELP® ITCH RELIEF SHAMPOO

  • For external use only.
  • Always use DERMIKELP® ITCH RELIEF SHAMPOO exactly as instructed. You should check with your doctor or pharmacist if you are unsure.
  • Wet your hair, apply DERMIKELP® ITCH RELIEF SHAMPOO and gently massage into your scalp.
  • Rinse and repeat as required.
  • If you have the impression that the effect of DERMIKELP® ITCH RELIEF SHAMPOO is too strong or too weak, talk to your doctor or pharmacist.

If you use more DERMIKELP® ITCH RELIEF SHAMPOO than you should:

  • If you or your child accidentally ingested DERMIKELP® ITCH RELIEF SHAMPOO, 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 shampoo with you so the doctor will know what you have taken.

If you forget to use DERMIKELP® ITCH RELIEF SHAMPOO:

Apply daily as required.

POSSIBLE SIDE EFFECTS

DERMIKELP® ITCH RELIEF SHAMPOO can have side effects.

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

If any of the following happens, stop using DERMIKELP® ITCH RELIEF SHAMPOO 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 inswallowing 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®ITCH RELIEF SHAMPOO. 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® ITCH RELIEF SHAMPOO

  • Store at or below 25?.
  • Protect from sunlight.
  • Keep bottle 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® ITCH RELIEF SHAMPOO

White, plastic bottle packed into an outside carton.
Pack size: 250 ml.

IDENTIFICATION OF DERMIKELP® ITCH RELIEF SHAMPOO

Off-white to beige shampoo with characteristic odour.

REGISTRATION NUMBER

To be allocated by Council.

NAME AND ADDRESS OF THE REGISTRATION HOLDER

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

DATE OF PUBLICATION

October 2014

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