E45 cream

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Navodilo za uporabo Navodilo za uporabo (PIL)
24-03-2023
Lastnosti izdelka Lastnosti izdelka (SPC)
24-03-2023

Aktivna sestavina:

Liquid paraffin light; White soft paraffin; Wool fat

Dostopno od:

Karo Healthcare UK Ltd

INN (mednarodno ime):

Liquid paraffin light; White soft paraffin; Wool fat

Odmerek:

126mg/1gram ; 145mg/1gram ; 10mg/1gram

Farmacevtska oblika:

Cutaneous cream

Pot uporabe:

Cutaneous

Razred:

No Controlled Drug Status

Tip zastaranja:

Never Valid To Prescribe As A VMP

Povzetek izdelek:

BNF: 13020100; GTIN: 5000167017571 5000167010220 5000167029550 5000167016598

Navodilo za uporabo

                                CREAM
CREAM
CREAM
BN
EXP
50g
Remove peelable
seal before use
Remove peelable
seal before use
Remove peelable
seal before use
Remove peelable
seal before use
Fire hazard. Do not smoke or go near
naked
flames; clothing & bedding with this
product
dried on them can catch fire easily.
STRAIGHTFORWARD SKINCARE
STRAIGHTFORWARD SKINCARE
STRAIGHTFORWARD SKINCARE
dry/flaky skin
eczema
itchy skin
dry psoriasis
sunburn
dry/flaky skin
eczema
itchy skin
dry psoriasis
sunburn
Treatment for dry skin
conditions including:
Treatment for dry skin
conditions including:
WHITE SOFT PARAFFIN,
LIGHT LIQUID PARAFFIN,
ANHYDROUS LANOLIN (MEDILAN
®
)
WHITE SOFT PARAFFIN,
LIGHT LIQUID PARAFFIN,
ANHYDROUS LANOLIN
(MEDILAN
®
)
1. WHAT E45 CREAM IS USED FOR: E45 cream has been clinically proven
to treat and soothe dry, itching, flaking, chapped, rough and
calloused
skin, sunburn and detergent hands. Non greasy formula leaves skin soft
& relieved. Perfume free.
2. BEFORE YOU USE E45 CREAM: E45 cream can be used everyday by
the whole family, including infants over the age of 1 month. Do not
use if
allergic to any of the ingredients. Use this medicine only on your
skin.
Do not use near the mouth, inner nose, eyes, genital area or on broken
skin. Check that the tube seal is intact before first use, then remove
it.
E45 cream contains: Cetyl alcohol which may cause local skin reactions
(e.g.
contact dermatitis). E216 and E218 which may cause allergic reactions
(possibly
delayed). Do not smoke or go near naked flames - risk of severe burns.
Fabric
(clothing, bedding, dressings etc) that has been in contact with this
product
burns more easily and is a serious fire hazard. Washing clothing and
bedding
may reduce product build-up but not totally remove it. Speak to your
doctor if
you are using minoxidil. Not recommended during breastfeeding.
3. HOW TO USE E45 CREAM: Apply to the affected skin 2 or 3 times
daily.
For external use only. If symptoms persist, consult your doctor.
4. POSSIBLE SIDE EFFECTS: Occasionally, allergic reaction or worsening
of ac
                                
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Lastnosti izdelka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
E45 Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Anhydrous Lanolin
1.0%
w/w
White Soft Paraffin
BP
14.5%
w/w
Light Liquid Paraffin
PhEur
12.6%
w/w
Excipient(s) with known effect:
Cetyl alcohol 0.5% w/w
Methyl parahydroxybenzoate (E218) 0.15% w/w
Propyl parahydroxybenzoate (E216) 0.04% w/w
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
A cream
Smooth cream, white or practically white with a slight odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of dry skin conditions, where the use of an
emollient is indicated, such as flaking, chapped skin, ichthyosis,
traumatic dermatitis, sunburn, the dry stage of eczema and certain dry
cases of psoriasis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults, the elderly, children and infants over the age of 1 month -
apply to the
affected part two or three times daily.
METHOD OF ADMINISTRATION
For topical administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to white soft paraffin, light liquid paraffin and
anhydrous lanolin or to any of the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only
Cetyl alcohol may cause local skin reactions (e.g. contact
dermatitis).
Methyl and Propyl parahydroxybenzoate may cause allergic reactions
(possibly
delayed).
If rash develops, use of the product should be discontinued.
Instruct patients not to smoke or go near naked flames – risk of
severe burns. Fabric
(clothing, bedding, dressings etc) that has been in contact with this
product burns
more easily and is a serious fire hazard. Washing clothing and bedding
may reduce
product build-up but not totally remove it.
The product should not be applied to the mucous membranes or to broken
skin.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The absorption of topical minoxidil can be increased by concurrent
topical
soft paraffin. This could potentiate the hypotensive effects of
vasod
                                
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