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Oilatum Shower Gel Fragrance Free 150g

Oilatum Shower Gel Fragrance Free 150g

Oilatum

General Sales List (GSL) topical medicinal product; emollient shower gel
  • UK MHRA Licensed medicinal product: Marketing Authorisation number PL 00240/0465 (Oilatum Shower Gel Fragrance Free).
  • Classified in the United Kingdom as a General Sales List (GSL) medicine.
  • SmPC and PIL approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and published on the electronic medicines compendium (emc).
  • Part of the Oilatum range of emollient products for dry and eczema Prone skin marketed by Thornton & Ross / STADA group in various markets.
Topical emollient gel for the treatment of eczema and related dry skin conditions; light liquid paraffin 70% w/w

Description

Oilatum Shower Gel Fragrance-Free 150g is a non-foaming emollient shower gel containing light liquid paraffin 70% w/w. It is licensed as a General Sales List (GSL) medicinal product for the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions. The gel is applied to wet skin in the shower or bath, where it forms an occlusive oil film in the stratum corneum to reduce transepidermal water loss, soothe irritation and help restore skin hydration. It is fragrance-free, suitable for adults, children and the elderly, and can be used as frequently as necessary on itchy, irritating dry skin conditions such as eczema and dermatitis.

Bnefits

  • Treats contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions
  • Provides emollient action by forming an occlusive oil film that reduces water loss from the skin surface and improves hydration
  • Soothes, moisturises and conditions itchy, irritating dry skin such as eczema and dermatitis
  • Non-foaming, fragrance-free gel suitable for sensitive and dry skin
  • Can be used frequently by adults, children and the elderly as part of daily washing or showering routines
  • Helps relieve dryness and pruritus associated with chronic dry skin conditions
  • Licensed over-the-counter (General Sales List) medicinal product with MHRA-approved SmPC and PIL

Indications

  • Treatment of contact dermatitis
  • Treatment of atopic dermatitis
  • Treatment of senile pruritus
  • Treatment of ichthyosis
  • Treatment of related dry skin conditions
  • Treatment of itchy, irritating dry skin conditions such as eczema and dermatitis

Composition

  • Active ingredient: Light liquid paraffin 70% w/w (each gram of gel contains 700 mg light liquid paraffin).
  • Excipients: Polyethylene.
  • Excipients: 2-octadodecanol.
  • Excipients: Polyethylene glycol 400 dilaurate.
  • Excipients: Polyoxyethylene 40 sorbitol septaoleate.
  • Excipients: Polypropyleneglycol-2-myristyl ether propionate.
  • Excipients: Polyphenylmethyl siloxane copolymer.

Formulation

  • Pharmaceutical form: Gel for topical use.
  • Non-foaming emollient shower gel for application to wet skin.
  • Active emollient agent (light liquid paraffin) forms an occlusive oil film in the stratum corneum to prevent excessive evaporation of water from the skin surface and improve hydration.
  • Fragrance-free formulation suitable for sensitive and dry skin.

Packaging

  • High density polyethylene tube fitted with a polypropylene screw cap (as described in SmPC), available in pack sizes including 25 g, 30 g, 125 g and 150 g (not all pack sizes may be marketed).
  • Polyethylene/ethylene vinyl alcohol copolymer (EVOH)/polyethylene laminate with polyethylene shoulder, membrane seal and polypropylene cap for certain pack sizes.
  • Retail presentation for this listing: 150 g tube of Oilatum Shower Gel Fragrance-Free.

Usage

  • For cutaneous use only.
  • Oilatum Shower Gel Fragrance-Free should always be applied to wet skin, normally as a shower gel.
  • Shower or wash as usual. When the skin is still wet, rub the gel between wet hands and apply liberally to the affected areas of skin, massaging gently.
  • If applying to another person, ensure both your hands and the area being treated are wet before application.
  • Rinse with warm water.
  • Lightly pat the skin dry with a soft towel; do not rub, as this may remove the product from the skin.
  • Use every time you wash or shower for itchy, irritating dry skin conditions such as eczema and dermatitis, or as directed by a healthcare professional.
  • Avoid getting the gel into the eyes or mouth; if contact occurs, rinse thoroughly with water.
  • Take care to avoid slipping in the bath or shower, as the product can make surfaces more slippery.
  • Do not smoke or go near naked flames after application and be aware that fabrics (clothing, bedding, dressings etc.) in contact with the product may be more easily ignited and pose a fire hazard.

Contraindications

  • Hypersensitivity to light liquid paraffin (LLP).
  • Hypersensitivity to any of the excipients listed in the product.
  • Use on greasy skin is contraindicated according to the patient leaflet.
  • Do not use if any signs of allergy or intolerance (such as rash, redness, irritation or swelling) occur after application; discontinue use and seek medical advice.

Adverse Effects

  • Rare (post-marketing): Application site reactions including irritation, rash, erythema and pruritus.
  • Rare (post-marketing): Application site hypersensitivity reactions including application site dermatitis.
  • Additional adverse reactions reported in the patient leaflet include redness of the skin, rash, irritation or itching, and allergic-type reactions including red, swollen, inflamed skin at the application site.
  • Accidental ingestion may cause gastrointestinal irritation with symptoms such as nausea, vomiting and diarrhoea; management is symptomatic and as clinically indicated.

Storage Conditions

  • Store below 25°C.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date stated on the end of the tube (expiry date refers to the last day of the stated month).
  • Dispose of unused medicine in accordance with local requirements; do not dispose of via wastewater or household waste.
  • Shelf life of the product as packaged for sale is 3 years (as stated in the SmPC).

Duration

May be used as frequently and for as long as necessary to control dry skin conditions, including daily use with each wash or shower. There is no fixed maximum duration specified in the SmPC or PIL; use should follow the advice of a doctor or pharmacist, particularly for persistent or worsening symptoms.

Onset

Not publicly listed (no specific onset-of-action timeframe is quantified in the SmPC or PIL).

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