Oilatum Emollient 63.4% w/w Bath Additive
- Name:
Oilatum Emollient 63.4% w/w Bath Additive
- Company:
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/10/19


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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
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Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 3 October 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 29 April 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 29 April 2016 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 10 July 2015 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 7
Marketing Authorisation Holder address updated to:
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
Updated on 10 July 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 22 May 2015 SmPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 22 May 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 8 July 2014 PIL
Reasons for updating
- Change of licence holder
Updated on 6 December 2013 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Current:
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland
Previous:
GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland
Section 8: New PA no:
PA 0678/113/001
Updated on 7 June 2012 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 18 August 2011 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 18 August 2011 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 11 May 2010 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 6.1 has been updated to include Macrogol 400 dilaurate instead of polyethylene glycol 400.
section 4.2 is updated to include special populations (elderly, children) "Oilatum Emollient is indicated for use in adults (including the elderly), children and infants’.
Section 4.4: the following statements have been added : Patients should be advised to use care to avoid slipping in the bath. Avoid contact with eyes. If a rash or skin irritation should occur, stop using the product and consult your doctor
4.3 Contraindications: ‘Hypersensitivity to the active substance or any of the excipients’
Updated on 15 August 2009 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section10, the date of approval has been updated.
Updated on 17 March 2007 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Supply through pharmacy only
Updated on 30 August 2006 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 24 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only