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:

The Boots Company 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; GTIN: 5000167084979

Patient Information leaflet

Calamine Lotion B.P.
Calamine, Zinc Oxide
 MINOR SKIN RASHES
 SKIN IRRITATION
 ADULTS AND CHILDREN
READ ALL OF THIS LABEL FOR FULL INSTRUCTIONS.
WHAT THIS MEDICINE IS FOR
A mild astringent lotion for the relief of minor skin rashes and
irritation.
BEFORE YOU USE THIS MEDICINE
X DO NOT USE:

IF YOU ARE ALLERGIC to any of the ingredients

IF YOU ARE HAVING AN X-RAY because it may affect the results)
YOU CAN use this medicine if you are pregnant or breastfeeding.

HOW TO USE THIS MEDICINE
Check the cap seal is not broken before first use. If it is, do not
use the lotion.
Shake the bottle before use.
ADULTS AND CHILDREN: Apply to the affected area when you need to.
For use on the skin only.
If symptoms do not go away talk to your doctor.
If anyone accidentally swallows some: Talk to a pharmacist or doctor.
POSSIBLE SIDE EFFECTS
Most people will not have problems, but some may get some of these:

Skin rash, red or itchy skin (allergic reaction)

Skin irritation
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 on 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
provide more information on the safety of this medicine.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Use by the date on the label edge.
ACTIVE INGREDIENTS
This lotion contains Calamine 15% w/v, Zinc Oxide 5% w/v.
Also contains: purified water, glycerol, bentonite, sodium citrate,
phenol.
PL 00014/5471
Text prepared 10/14
Manufactured by BCM Ltd Nottingham NG2 3AA for the MAH: The Boots
Company PLC
Nottingham NG2 3AA
NG2 3AA
If you need more advice ask your pharmacist.
200 ML E

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