Calamine lotion

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calamine; Zinc oxide; Glycerol; Bentonite; Sodium citrate; Phenol liquefied

Available from:

Bell,Sons & Co (Druggists) Ltd

ATC code:

n/a

INN (International Name):

Calamine; Zinc oxide; Glycerol; Bentonite; Sodium citrate; Phenol liquefied

Dosage:

150mg/1ml ; 50mg/1ml ; 50mg/1ml ; 30mg/1ml ; 5mg/1ml ; 5mg/1ml

Pharmaceutical form:

Cutaneous liquid

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13030000; GTIN: 5017848249367

Patient Information leaflet

Calamine
lotion BP
_ 200ML_
SOOTHING PROTECTIVE LOTION
ABOUT THIS PRODUCT:
Vantage Calamine Lotion BP is applied to the
skin to relieve minor irritation and sunburn.
DIRECTIONS FOR USE:
Liquid for topical use (application to
the skin). Shake the bottle thoroughly
before use.
Adults and children: Apply to the affected
area with cotton wool.
If you accidentally swallow Vantage
Calamine Lotion it should not cause any
problems, but if you notice anything consult
your doctor or pharmacist.
WARNINGS:
For external use only
Do not use if you allergic to any of the
ingredients with symptoms of itching,
rashes or difficulty breathing.
Do not use on broken skin.
This product is safe to use if you are
pregnant or breast- feeding.
Avoid contact with the eyes, mucous
membranes and other sensitive parts of
the body.
If you have an allergic reaction or notice
any other side effects discontinue use and
consult your doctor or pharmacist.
ACTIVE INGREDIENTS:
Calamine 15%w/v and Zinc Oxide 5%w/v.
OTHER INGREDIENTS:
Bentonite E558, Sodium Citrate E331,
Phenol, Glycerol, E422 and Purified Water.
STORAGE:
_Manufacturer and Product _
_Licence Holder: _
BELL, SONS & CO (DRUGGISTS) LTD.,
SOUTHPORT, PR9 9AL.
_Packed for:_
AAH PHARMACEUTICALS LTD.,
COVENTRY CV2 2TX.
C71-0758 VER A REVISED SEP 2010.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN
VAN1562L PL 3105/0011
5025903020776
_200ml_
CALAMINE AND ZINC OXIDE
100m 100y
100M
PMS 286
Crease
CMYK
Template
JOB NO
DATE
00736
21.10.10
ITEM
Vantage Calamine Lotion
WIDTH
HEIGHT
SCALE
XXX mm
XXX mm
100%
ARTWORKER
EC
Barcode: 5025903020776
VAN: VAN1562L
blue. brand creative ltd
ground floor studios, 23 charis avenue,
bristol bs10 5jd
tel: [phone]
www.bluebrandcreative.eu
FRONT
_169 MM_
_Workstation: _
_Operator: _
_Version _
_Date: _
_Time: _
_Comments: Illustrator CS3_
_Dimensions: 169mm x 65mm_
_Proof required: _
_Outside Print_
_Inside Print_
_Litho_
_Flexo_
_Gravure_
_Mock-up_
_ Telephone: [phone] _
_• _
_Mobile • 07798677162 • Email • [e-mail]_
_Job

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Calamine Lotion BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
% w/v
Calamine BP
15
Zinc Oxide Ph Eur
5
3
PHARMACEUTICAL FORM
Lotion
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of minor skin rashes and irritation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, children and elderly
To be applied when required to the affected area.
For topical application.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Shake the bottle.
For external use only.
Keep all medicines out of the reach of children.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No clinically significant interactions known.
May mask x-ray pictures under certain circumstances.
4.6
FERTILITY, PREGNANCY AND LACTATION
The safety of Calamine Lotion during pregnancy and lactation has not
been
established but used during these periods is not considered to
constitute a
hazard.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No adverse effects known.
4.8
UNDESIRABLE EFFECTS
Occasional hypersensitivity or irritant reactions.
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.
4.9
OVERDOSE
If ingested symptoms of overdosage include anorexia, nausea, vomiting,
epigastric discomfort and diarrhoea. Treatment consists of symptomatic
measures only.
5
PHARMACOLOGICAL PROPERTIES
5.1
PHARMACODYNAMIC PROPERTIES
Calamine has a mild astringent action on the skin.
5.2
PHARMACOKINETIC PROPERTIES
None known.
5.3
PRECLINICAL SAFETY DATA
There are no preclinical data of relevance to the prescriber which are
additional to that already included.
6
PHARMACEUTICAL PARTICULARS
6.1
LIST O