Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for Cutaneous Solution

国家: 马耳他

语言: 英文

来源: Medicines Authority

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下载 资料单张 (PIL)
27-06-2023
下载 产品特点 (SPC)
01-04-2022

可用日期:

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 Hoofddorp Noord-Holland 2132 WT, Netherlands

ATC代码:

D08AE05

INN(国际名称):

CHLOROXYLENOL 4.8 % (W/V)

药物剂型:

CONCENTRATE FOR CUTANEOUS SOLUTION

组成:

CHLOROXYLENOL 4.8 % (W/V)

处方类型:

OTC

治疗领域:

ANTISEPTICS AND DISINFECTANTS

產品總結:

Licence number in the source country: NOT APPLICAPABLE

授权状态:

Authorised

授权日期:

2022-04-14

资料单张

                                Page 1
PACKAGING LEAFLET: INFORMATION FOR THE USER
DETTOL ANTISEPTIC LIQUID CHLOROXYLENOL 4.8% W/V FOR
CUTANEOUS SOLUTION
FOR EXTERNAL USE ONLY
IMPORTANT INFORMATION ABOUT THE INGREDIENTS OF DETTOL ANTISEPTIC
LIQUID CHLOROXYLENOL
4.8% W/V
This product contains Chloroxylenol 4.8 w/w as the active ingredient
which may cause skin
irritation (concentration will be expressed as per the local
agreement).
This medicine contains fragrance with d-Limonene and trace amounts of
Benzyl Alcohol. D-
limonene and Benzyl Alcohol may cause allergic reactions. Benzyl
Alcohol may cause mild
local irritation.
It must be diluted with water before use
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Dettol
Antiseptic Liquid Chloroxylenol 4.8% w/v for Cutaneous Solution
carefully to get the
best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If any of the side effects gets serious, or if you notice any side
effect not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for cutaneous
solution is and what
it is used for
2.
Before you use Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for
cutaneous solution
3.
How to use Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for
cutaneous solution
4.
Possible side effects
5.
How to store Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for
cutaneous solution
6.
Further information
1.
WHAT DETTOL ANTISEPTIC LIQUID CHLOROXYLENOL 4.8% W/V
FOR CUTANEOUS SOLUTION IS AND WHAT IT IS USED FOR
Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for cutaneous
solution, which after
diluting in water to produce a milky solution, is a topical antiseptic
used for cleansing of
minor wounds such as cuts grazes and insect bites and stings.
It is in a concentrated form and requires dilution before use.
DO NOT USE DETTOL ANTISEPTIC LIQ
                                
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产品特点

                                Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for Cutaneous Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloroxylenol 4.8mg in 100mg concentrate for Cutaneous
solution Excipients with known effect:
Fragrances containing allergens*
*Contained within pine oil
For full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Concentrate for cutaneous solution. Clear, amber liquid
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antiseptic cleansing of cuts, bites, abrasions and insect bites and
stings.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For Cutaneous use
Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v should not be used
undiluted
Cuts, bites, abrasions and insect stings - wash the area with 50 ml
Dettol
Antiseptic Liquid Chloroxylenol 4.8% w/v diluted to one litre (5%,
1:20)
with water and cover with dry gauze or lint.
Once diluted the liquid becomes a milky white, opaque solution with
pine
odour. Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v should not be
used undiluted
PAEDIATRIC PATIENTS
Not to be used on children under 12 months.
4.3
CONTRAINDICATIONS
Known hypersensitivity to the active substance or any of the
excipients
Eczematous conditions.
Page 2
Not to be used on children under 12 months of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
This product is only suitable for wound cleansing as a first aid
measure
and is not suitable for surgical antisepsis or use in a hospital
setting.
Following accidental ingestion, it is advised to consider dilution
with milk or
water if vomiting has not occurred. If skin or eye contamination has
occurred,
copious irrigation should be performed. This should be followed by a
careful
eye examination for corneal burns. If corneal burns are noted,
ophthalmologic
consultation should be obtained
Do not use in or around the 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.
Th
                                
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