Dettol Antiseptic Disinfectant 4.8 % w/v Concentrate for Cutaneous Solution
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 September 2024
File name
250ml BACK LABEL Mar 21.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 20 September 2024
File name
250ml BACK LABEL Mar 21.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 20 September 2024
File name
IE SPC Dettol Liquid Mar21.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Supply through general sale
Updated on 20 September 2024
File name
250ml BACK LABEL Mar 21.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 04 August 2022
File name
250ml BACK LABEL TR2218467B - CRN009ZY0.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 04 August 2022
File name
IE SPC Dettol Liquid Mar21 CRN009ZY0.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 04 August 2022
File name
250ml BACK LABEL TR2218467B - CRN009ZY0.pdf
Reasons for updating
- New PIL for new product
Updated on 04 August 2022
File name
IE SPC Dettol Liquid Mar21 CRN009ZY0.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 05 April 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 05 April 2018
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and Method of Administration:
Reworded as follows:-
Posology:
Adults: Wash the affected area with product at 5% dilution (50ml product in 1 litre water)
Paediatric population: Children over the age of 1 year - as above of adult. Children under the age of 1 year - not for use in children under one year of age.
Method of Administration:
Apply topically to relevant area as requested. Do not use undiluted.
Section 4.3 Contraindications:
Reworded as follows:-
Hypersensitivity to chloroxylenol or any of the excipients listed in Section 6.1
Do not use on eczematous conditions. Not for use on children under one year of age
Section 4.4 Special warnings and special precautions for use:
Addition of the following wording:-Not for use around eyes, ears, nose or mouth. If contact is made, wash thoroughly with cold water. Not for use on large areas of the body or on sensitive skin.
Section 4.6 Fertility, Pregnancy & Lactation:
Reworded as follows:-
Pregnancy: No effects during pregnancy are anticipated, since systemic exposure from topical chloroxylenol use is negligible. As with all medicines, this product should be used with caution during pregnancy.
Breast-feeding: Is it unknown whether chloroxylenol or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Application of the product to the breast is not recommended during breast-feeding.
Lactation: No data on human fertility are available.
Section 4.8 Undesirable Effects:
Addition of frequencies & MEDdra table
Addition of paragraph on how to Report a Suspected Adverse Event.
Section 4.9 Overdose:
Reworded as follows:
Symptoms: Topical application of undiluted chloroxylenol can cause skin burning.
Oral ingestion may result in pharyngeal erosion, laryngeal oedema, stomatitis, bradycardia, hypotension, renal failure and CNS depression. Pulmonary aspiration following ingestion may result in pheumonia, acute respiratory distress syndrome and cardiorespiratory arrest. There have been reported of deaths by excessive consumption.
Management: In the case of accidental ingestion or excess exposure, wash out mouth and drink plenty of water or milk and contact your doctor immediately. Careful observation of airway patency for 24-48 hours should be made post-ingestion.
Reworded as follows:-
Posology:
Adults: Wash the affected area with product at 5% dilution (50ml product in 1 litre water)
Paediatric population: Children over the age of 1 year - as above of adult. Children under the age of 1 year - not for use in children under one year of age.
Method of Administration:
Apply topically to relevant area as requested. Do not use undiluted.
Section 4.3 Contraindications:
Reworded as follows:-
Hypersensitivity to chloroxylenol or any of the excipients listed in Section 6.1
Do not use on eczematous conditions. Not for use on children under one year of age
Section 4.4 Special warnings and special precautions for use:
Addition of the following wording:-Not for use around eyes, ears, nose or mouth. If contact is made, wash thoroughly with cold water. Not for use on large areas of the body or on sensitive skin.
Section 4.6 Fertility, Pregnancy & Lactation:
Reworded as follows:-
Pregnancy: No effects during pregnancy are anticipated, since systemic exposure from topical chloroxylenol use is negligible. As with all medicines, this product should be used with caution during pregnancy.
Breast-feeding: Is it unknown whether chloroxylenol or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Application of the product to the breast is not recommended during breast-feeding.
Lactation: No data on human fertility are available.
Section 4.8 Undesirable Effects:
Addition of frequencies & MEDdra table
Addition of paragraph on how to Report a Suspected Adverse Event.
Section 4.9 Overdose:
Reworded as follows:
Symptoms: Topical application of undiluted chloroxylenol can cause skin burning.
Oral ingestion may result in pharyngeal erosion, laryngeal oedema, stomatitis, bradycardia, hypotension, renal failure and CNS depression. Pulmonary aspiration following ingestion may result in pheumonia, acute respiratory distress syndrome and cardiorespiratory arrest. There have been reported of deaths by excessive consumption.
Management: In the case of accidental ingestion or excess exposure, wash out mouth and drink plenty of water or milk and contact your doctor immediately. Careful observation of airway patency for 24-48 hours should be made post-ingestion.
Updated on 05 April 2018
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and Method of Administration:
Reworded as follows:-
Posology:
Adults: Wash the affected area with product at 5% dilution (50ml product in 1 litre water)
Paediatric population: Children over the age of 1 year - as above of adult. Children under the age of 1 year - not for use in children under one year of age.
Method of Administration:
Apply topically to relevant area as requested. Do not use undiluted.
Section 4.3 Contraindications:
Reworded as follows:-
Hypersensitivity to chloroxylenol or any of the excipients listed in Section 6.1
Do not use on eczematous conditions. Not for use on children under one year of age
Section 4.4 Special warnings and special precautions for use:
Addition of the following wording:-Not for use around eyes, ears, nose or mouth. If contact is made, wash thoroughly with cold water. Not for use on large areas of the body or on sensitive skin.
Section 4.6 Fertility, Pregnancy & Lactation:
Reworded as follows:-
Pregnancy: No effects during pregnancy are anticipated, since systemic exposure from topical chloroxylenol use is negligible. As with all medicines, this product should be used with caution during pregnancy.
Breast-feeding: Is it unknown whether chloroxylenol or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Application of the product to the breast is not recommended during breast-feeding.
Lactation: No data on human fertility are available.
Section 4.8 Undesirable Effects:
Addition of frequencies & MEDdra table
Addition of paragraph on how to Report a Suspected Adverse Event.
Section 4.9 Overdose:
Reworded as follows:
Symptoms: Topical application of undiluted chloroxylenol can cause skin burning.
Oral ingestion may result in pharyngeal erosion, laryngeal oedema, stomatitis, bradycardia, hypotension, renal failure and CNS depression. Pulmonary aspiration following ingestion may result in pheumonia, acute respiratory distress syndrome and cardiorespiratory arrest. There have been reported of deaths by excessive consumption.
Management: In the case of accidental ingestion or excess exposure, wash out mouth and drink plenty of water or milk and contact your doctor immediately. Careful observation of airway patency for 24-48 hours should be made post-ingestion.
Reworded as follows:-
Posology:
Adults: Wash the affected area with product at 5% dilution (50ml product in 1 litre water)
Paediatric population: Children over the age of 1 year - as above of adult. Children under the age of 1 year - not for use in children under one year of age.
Method of Administration:
Apply topically to relevant area as requested. Do not use undiluted.
Section 4.3 Contraindications:
Reworded as follows:-
Hypersensitivity to chloroxylenol or any of the excipients listed in Section 6.1
Do not use on eczematous conditions. Not for use on children under one year of age
Section 4.4 Special warnings and special precautions for use:
Addition of the following wording:-Not for use around eyes, ears, nose or mouth. If contact is made, wash thoroughly with cold water. Not for use on large areas of the body or on sensitive skin.
Section 4.6 Fertility, Pregnancy & Lactation:
Reworded as follows:-
Pregnancy: No effects during pregnancy are anticipated, since systemic exposure from topical chloroxylenol use is negligible. As with all medicines, this product should be used with caution during pregnancy.
Breast-feeding: Is it unknown whether chloroxylenol or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Application of the product to the breast is not recommended during breast-feeding.
Lactation: No data on human fertility are available.
Section 4.8 Undesirable Effects:
Addition of frequencies & MEDdra table
Addition of paragraph on how to Report a Suspected Adverse Event.
Section 4.9 Overdose:
Reworded as follows:
Symptoms: Topical application of undiluted chloroxylenol can cause skin burning.
Oral ingestion may result in pharyngeal erosion, laryngeal oedema, stomatitis, bradycardia, hypotension, renal failure and CNS depression. Pulmonary aspiration following ingestion may result in pheumonia, acute respiratory distress syndrome and cardiorespiratory arrest. There have been reported of deaths by excessive consumption.
Management: In the case of accidental ingestion or excess exposure, wash out mouth and drink plenty of water or milk and contact your doctor immediately. Careful observation of airway patency for 24-48 hours should be made post-ingestion.
Updated on 24 August 2012
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 24 August 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated section 6.5 of the SmPC to remove reference to "Glass bottles with hard plastic screw cap"
Updated on 24 August 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated section 6.5 of the SmPC to remove reference to "Glass bottles with hard plastic screw cap"
Updated on 15 June 2012
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
To correct date of first authorisation
Updated on 15 June 2012
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
To correct date of first authorisation
Updated on 19 October 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 1 - addition of strength and pharmaceutical form to name
Section 9 - date of last renewal updated
Section 9 - date of last renewal updated
Updated on 19 October 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
Section 1 - addition of strength and pharmaceutical form to name
Section 9 - date of last renewal updated
Section 9 - date of last renewal updated
Updated on 10 May 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 7. Change of address of Marketing Authorisation Holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
Updated on 10 May 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 7. Change of address of Marketing Authorisation Holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
Updated on 19 May 2005
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 19 May 2005
Reasons for updating
- Improved electronic presentation
Updated on 10 August 2004
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 10 August 2004
Reasons for updating
- New SPC for medicines.ie