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:

Sigma Pharmaceuticals Plc

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

Patient Information leaflet

CALAMINE
LOTION BP
Soothing protective lotion
CALAMINE AND
ZINC OXIDE
200ML
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 Sainsbury’s
calamine lotion it should not cause any problems, but if
you do notice anything consult your doctor or pharmacist.
6005129
11.16
R1153
Manufacturer and product licence holder:
Bell, Sons & Co (Druggists) Ltd, Southport, PR9 9AL.
PL03105/0011
Produced for
SAINSBURY’S SUPERMARKETS LTD, LONDON EC1N 2HT.
C71-0674 Ver. E Revised: 12/2016
STORAGE
Do not store above 25ºC.
OTHER INGREDIENTS
Bentonite E558, Sodium Citrate E331, Phenol, Glycerol
E442 and Purified Water.
ACTIVE INGREDIENTS
Calamine 15%w/v and Zinc Oxide 5%w/v.
Sainsbury’s Calamine Lotion BP is applied to the
skin to relieve irritation and sunburn.
WARNINGS
• Do not use if you are 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. • FOR EXTERNAL USE ONLY.
• Ask your doctor before use if having an x-ray, as the product
may mask the x-ray picture.
• Avoid contact with 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.
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
label. 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.
169.00 mm
65.00 mm
Gloss Varnish guide
Braille guide
Braile reads:
Sainsbury’s Calamine Lotion BP
KJ32999 KSJ333282 -v2-1
23-Dec-16
Calamine Lotion 200ml
AJS Cutter Guide

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