Dettol Antiseptic Disinfectant 4.8% w/v, concentrate for cutaneous solution

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Chloroxylenol

থেকে পাওয়া:

Reckitt Benckiser Ireland Ltd

এটিসি কোড:

D08AE; D08AE05

INN (আন্তর্জাতিক নাম):

Chloroxylenol

ডোজ:

4.8 percent weight/volume

ফার্মাসিউটিকাল ফর্ম:

Concentrate for cutaneous solution

প্রেসক্রিপশন টাইপ:

Product not subject to medical prescription

থেরাপিউটিক এলাকা:

Phenol and derivatives; chloroxylenol

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1983-04-01

তথ্য লিফলেট

DETTOL
ANITSEPTIC DISINFECTANT 4.8% W/V
CONCENTRATE FOR CUTANEOUS SOLUTION
CHLOROXYLENOL
1.
WHAT IS DETTOL ANTISEPTIC DISINFECTANT AND WHAT IS IT USED FOR?
Dettol Antiseptic Disinfectant is a concentrated antiseptic solution
for the antiseptic cleansing of minor
cutaneous wounds caused by cuts, bites, grazes, and insect stings. It
can also be used for personal
hygiene.
2.
BEFORE YOU USE DETTOL ANTISEPTIC DISINFECTANT:
DO NOT USE

ON ECZEMA OR SIMILAR SKIN CONDITIONS

IF YOU ARE ALLERGIC TO CHLOROXYLENOL OR ANY OF THE INGREDIENTS

AFTER THE EXPIRY DATE PRINTED ON THE BOTTLE

DO NOT USE UNDILUTED.
DO NOT SWALLOW. DO NOT USE ON CHILDREN LESS THAN 1 YEAR OLD. NOT
RECOMMENDED FOR USE AROUND CATS.
USE WITH CAUTION IF PREGNANT OR BREAST-FEEDING
3.
HOW TO USE DETTOL ANTISEPTIC DISINFECTANT:
For external use only.
ANTISEPTIC WOUND CLEANSING FOR CUTS, GRAZES, BITES & STINGS: Dilute
50ml to 1 litre with water or dilute 1
capful to half pint with water. Cover with clean, dry dressing.
MIDWIFERY: Dilute 25ml to 1 litre with water or dilute 1 capful to 1
pint with water for external antisepsis.
BATHING: Dilute 1-2 capfuls to bath water. If swallowed, wash out
mouth and drink plenty of water or milk. If
contact is made with the eyes, wash thoroughly with cold water. In
both cases consult your doctor and take
this bottle with you.
4.
POSSIBLE SIDE EFFECTS:
May cause skin discolouration, skin irritation, burns, rash, itching,
redness, or inflammation. Oral ingestion
may cause erosion of the throat, swelling of the larynx, mouth ulcers,
low resting heart rate, and
depression.
This medicine contains trace amounts of benzyl alcohol and the
fragrance with D-Limonene.
Benzyl alcohol may cause mild local irritation.
D-limonene and benzyl alcohol may cause allergic reactions.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or nurse.
You can also report side effects directly
via HPRA Pharmacovigilance, Website: www.hpra.ie.
5.
FURTHER INFORMATION
KEEP OUT OF THE SIGHT AND REACH OF CHILDR

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
11 March 2021
CRN009ZY0
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dettol Antiseptic Disinfectant 4.8% w/v, concentrate for cutaneous
solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Chloroxylenol 4.8% w/v
Excipient(s) with known effect:
Pine Oil (contains fragrance with d-Limonene and Benzyl Alcohol)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for cutaneous solution.
An amber coloured liquid with an odour of pine oil.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic for prophylaxis of topical infection in intact and
abraded skin and for skin preparation prior to surgical or
diagnostic procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
ADULTS:
Wash the affected area with product at 5% dilution (50 ml product in 1
litre of water)
PAEDIATRIC POPULATION:
CHILDREN OVER THE AGE OF 1 YEAR: As above for adults
CHILDREN UNDER THE AGE OF 1 YEAR: Not for use in children under 1 year
of age.
METHOD OF ADMINISTRATION:
Apply topically to relevant area as required.
Do not use undiluted.
4.3 CONTRAINDICATIONS
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 1 year of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If the condition persists or is aggravated, discontinue use and
consult the doctor.
For external use only. Do not use undiluted.
Not for use around eyes, ears, nose or mouth. If contact is made, wash
Health Products Regulatory Authority
11 March 2021
CRN009ZY0
Page 2 of 4
thoroughly with cold water.
Not for use on large areas of the body or on sensitive skin.
If swallowed, wash out mouth and drink plenty of water or milk. If
contact is made with eyes, wash thoroughly with cold
water. In both cases consult your doctor.
Keep out of the sight and reach of children.
This medicine contains trace amounts of Benzyl Alcohol.
Benzyl Alcohol may cause allergic reacti