Cetraben emollient 82.8% bath additive

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Liquid paraffin light

Fáanlegur frá:

Genus Pharmaceuticals Ltd

INN (Alþjóðlegt nafn):

Liquid paraffin light

Skammtar:

828mg/1gram

Lyfjaform:

Bath additive

Stjórnsýsluleið:

Cutaneous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 13020101; GTIN: 5030451003416

Upplýsingar fylgiseðill

25188502 PA1D8221D
Back label
PRINTED ON WHITE
Reverse of back label
PRINTED ON WHITE
ACTIVE INGREDIENTS: Light Liquid Paraffin Ph Eur
82.8% w/w. ALSO CONTAINS: C-12-13-Pareth-3 and
medium chain triglycerides.
PRECAUTIONS: Do not use if you are allergic to any of
the ingredients. Mild skin reactions have been seen
very rarely. This product makes skin and surfaces
slippery. Take care not to slip when entering or
leaving the bath. Avoid contact with the eyes. If
product comes into contact with eyes, wash out
with water.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not use after expiry date.
FURTHER INFORMATION: Cetraben
Emollient Bath Additive is a
fragrance free clear liquid.
PRODUCT LICENCE HOLDER:
Genus Pharmaceuticals,
Linthwaite, Huddersfield,
HD7 5QH, UK.
PL 06831/0260
MANUFACTURED BY:
Laleham Health & Beauty Ltd.,
Fairfield, Bradshaw Lane,
Greenhalgh, Kirkham,
Lancs. PR4 3JA, UK.
® Cetraben is a registered
trademark. *Trademark
Revised: March 2015
CETRABEN
EMOLLIENT BATH ADDITIVE
is an effective, moisturising and
protective oil for the symptomatic relief of
symptoms such as red, inflamed, damaged, dry
or chapped skin especially when associated
with eczema.
MHRA HEADER BOX
Product Title:
Component:
Pack size:
IG Code:
Dimensions:
Proof No.:
COLOURS USED
FONTS USED
Date:
PCP HEADER BOX
Operator:
Artwork No:
CRN:
Reason for change:
MHRA/IMB
submission required:
APPROVED BY
DATE
ISSUED BY
DATE
Suffix:
A
9 Blackthorn Road. Reigate. RH2 7ND.
Tel: [phone] [e-mail]
Cetraben Emollient Bath Additive
Portrait single ply back and back reverse label
500ml
25188502
110 x 50mm
2955C
326C
Tondo
Tondo Bold
Brail

Vara einkenni

OBJECT 1
CETRABEN EMOLLIENT BATH ADDITIVE / CETRABEN
BATH ADDITIVE
Summary of Product Characteristics Updated 13-Feb-2018 | Genus
Pharmaceuticals
1. Name of the medicinal product
Cetraben Emollient Bath Additive
Cetraben Bath Additive
2. Qualitative and quantitative composition
Light Liquid Paraffin 82.8% w/w
For excipients see section 6.1
3. Pharmaceutical form
Bath additive
Cetraben Emollient Bath Additive is a clear liquid with a faint odour.
4. Clinical particulars
4.1 Therapeutic indications
Cetraben Emollient Bath Additive is an emollient, moisturising and
protective oil for the symptomatic
relief of red, inflamed, damaged, dry or chapped skin, especially when
associated with endogenous or
exogenous eczema.
4.2 Posology and method of administration
Cetraben Emollient Bath Additive should be added to a warm water bath
or applied to wet skin before
showering.
Bath:
Adults:
Add one/two capfuls to a warm water bath
Children:
Add half/one capfuls to a warm water bath
Shower:.
Apply lightly using a wet sponge
4.3 Contraindications
Hypersensitivity to any of the ingredients
4.4 Special warnings and precautions for use
Allergy to any of the ingredients.
Care when entering or leaving the bath
Avoid contact with eyes.
4.5 Interaction with other medicinal products and other forms of
interaction
None known
4.6 Fertility, pregnancy and lactation
No special precautions required
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
Very rarely, mild skin reactions have been seen
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are
asked to report any suspected adverse reactions via the Yellow Card
Scheme at
www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the
Google Play or Apple App
Store.
4.9 Overdose
No cases of overdose have been reported. Patients should be advised
that if they accide