Zinc cream

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Zinc oxide

Dostupné z:

A A H Pharmaceuticals Ltd

INN (Medzinárodný Name):

Zinc oxide

Dávkovanie:

320mg/1gram

Forma lieku:

Cutaneous cream

Spôsob podávania:

Cutaneous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 13020200

Príbalový leták

_Data Matrix:_
_ _
21765213 VERIFIED
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
B
gill.kennedy
541870
11679
Update ingredient names in line
with EP and addition of reporting
of side effects statment
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Landscape peelable label
100g
21765213
32 x 155mm
1
10.11.2014
Process Cyan
Process Magenta
Process Yellow
Process Black
Keyline (non-printing)
Braille
Text Free Area (Non-printing)
Zinc & Castor Oil Cream
Braille BQ
Helvetica
Helvetica Neue
OCRB
Optima BQ
PRINT LAYOUT DIAGRAM
32MM 155MM MULTIPEEL WITH 40MM HINGE LEFT
X
155mm
FRONT FACE:
2mm Ø
RADIUS
CORNERS
2mm Ø
RADIUS
CORNERS
2mm Ø
RADIUS
CORNERS
32mm
6.5mm
32mm
32mm
1.5MM
155mm
FRONT FACE REVERSE:
41.5mm
(40mm HINGE)
1.5MM
155mm
CARRIER:
1.5MM
41.5mm
(40mm HINGE)
For symptomatic relief of nappy rash, and as a
protective water resistant cream for dry chapped
skin. If separation of the ointment occurs, re-mix
before use. APPLY THE OINTMENT TO THE SKIN.
ADULTS, THE ELDERLY AND CHILDREN: Apply to the
affected skin up to four times a day or at each nappy
change. FOR EXTERNAL USE ONLY.
CONTAINS REFINED ARACHIS OIL (PEANUT OIL). DO NOT
USE IF ALLERGIC TO PEANUT OR SOYA.
PEEL WHERE SHOWN FOR FURTHER PRECAUTIONS.
ACTIVE INGREDIENTS: zinc
oxide 7.5%w/w, virgin
castor oil 50.0%w/w.
ALSO CONTAINS: refined arachis
oil (peanut oil), cetostearyl
alcohol, white beeswax (E901). Do not store above
25°C. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Manufactured by the licence holder L.C.M. Ltd.,
Huddersfield, HD7 5QH for Thornton and Ross Ltd.,
Huddersfield, HD7 5QH, UK. PL 12965/0038
21765213
100G
Zinc & Castor Oil Cream contains zinc oxide, a mild
antiseptic and astringent for the skin, and castor oil
which helps soften dry hard and chapped skin.
1. BEFORE YOU USE THIS MEDICINE
DO NOT USE THE MEDICINE IF YOU OR YOUR
CHILD HAVE….
• An ALLERGY to REFINED ARACHIS OIL (PEANUT OIL), S

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zinc and Castor Oil Ointment BP or Zinc and Castor Oil Cream BP.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc oxide
7.5% w/w.
Excipient(s) with known effect
Refined Arachis Oil (30.5% w/w)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ointment.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For relief of the symptoms of nappy rash and as a protective water
resistant
cream for dry, chapped skin.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Topical. Applied directly to the skin.
Recommended doses and dosage schedules.
As required, up to four times daily or at each nappy change. The
product is
suitable for use by adults, children and the elderly.
4.3.
CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients listed.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Keep all medicines out of sight and reach of children.
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.
Zinc and Castor Oil Ointment BP contains Arachis Oil (peanut oil) and
should
not be applied by patients known to be allergic to peanut. As there is
a
possible relationship between allergy to peanut and allergy to Soya,
patients
with soya allergy should also avoid Zinc and Castor Oil Ointment BP.
or
Zinc and Castor Oil Cream BP contains Arachis Oil (peanut oil) and
should
not be applied by patients known to be allergic to peanut. As there is
a
possible relationship between allergy to peanut and allergy to Soya,
patients
with soya allergy should also avoid Zinc and Castor Oil Cream BP.
4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
May mask x-ray pictures under certain circumstances.
4.6.
PREGNANCY AND LACTATION
No information is available on the safety