Calamine Lotion BP

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALAMINE, ZINC OXIDE

Available from:

LCM Limited Linthwaite Laboratories, Huddersfield, HD7 5QH, United Kingdom

ATC code:

D02AB

INN (International Name):

CALAMINE 2.5 % (W/V) ZINC OXIDE 15 % (W/V)

Pharmaceutical form:

CUTANEOUS SUSPENSION

Composition:

CALAMINE 2.5 % (W/V) ZINC OXIDE 15 % (W/V)

Prescription type:

OTC

Therapeutic area:

EMOLLIENTS AND PROTECTIVES

Authorization status:

Withdrawn

Authorization date:

2006-10-31

Patient Information leaflet

CARRIER:
FRONT FACE:
FRONT FACE REVERSE:
PRINT LAYOUT DIAGRAM
65MM X 170MM MULTIPEEL WITH 50MM HINGE LEFT
MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Landscape peelable label
200ml
21479314
65mm x 170mm
1
05.09.2016
Calamine Lotion Care
Yes
A
gill.kennedy
683258
13167
Type II safety variation.
Braille BQ
Helvetica
OCRB
Optima BQ
Process Cyan
Process Magenta
Process Yellow
Process Black
Keyline (Does not print)
Text free area (Does not print)
Braille
21479314
Datamatrix:
VERIFIED
PEEL
HERE
IMPORTANT: PEEL THIS LABEL
AT CORNER AND READ BEFORE
USE. DO NOT TEAR OFF, RE-FIX FOR
FUTURE USE.
Symptomatic relief of mild sunburn and
minor skin conditions.
APPLY TO THE SKIN.
SHAKE THE BOTTLE.
ADULTS, THE ELDERLY AND CHILDREN:
Apply with a pad of cotton wool to the
affected skin as required.
FOR EXTERNAL USE ONLY.
PEEL WHERE SHOWN FOR FURTHER PRECAUTIONS.
ACTIVE INGREDIENTS: calamine 15% w/v,
zinc oxide 5% w/v.
ALSO CONTAINS: bentonite (E558), sodium
citrate, glycerol (E422), phenol and purified
water.
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, UK
for Thornton and Ross Ltd.,
Huddersfield, HD7 5QH, UK.
PL 12965/0003 MA213/00201
PIP: 103-0865 21479314
200ML
5 011309 020212
Calamine Lotion is a mild astringent and antiseptic.
It relieves the symptoms of mild sunburn and minor
skin conditions.
1. BEFORE YOU USE THIS MEDICINE
DO NOT USE THE MEDICINE IF YOU HAVE….
• An ALLERGY to any of the ingredients listed on the
front.
• Ask your doctor before use if having an x-ray, as
the product may mask the x-ray picture.
PREGNANT OR BREASTFEEDING….
Using Calamine Lotion during pregnancy and
breastfeeding is unlikely to have any ill effects when
used as directed. If unsure, talk to your doctor or
pharmacist.
2. POSSIBLE SIDE EFFECTS
Like all medici

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Calamine Lotion BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calamine 15.0% w/v
Zinc Oxide 5.0% w/v
3
PHARMACEUTICAL FORM
Cutaneous suspension
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For relief of the symptoms of mild sunburn and other minor skin
conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Topical. Applied directly to the skin.
Recommended dose and dosage schedule
The product is suitable for use by adults, children and the elderly.
Apply gently with a pad of cotton wool to the affected parts as
required.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Shake the bottle.
For external use only.
Keep all medicines away from children.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
May mask x-ray pictures under certain circumstances.
4.6
FERTILITY, PREGNANCY AND LACTATION
No evidence has been found as to the safety of the product when used
during
pregnancy and lactation. However, the product has been used for many
years without
any apparent ill effects.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None 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 national reporting system, ADR Reporting Website:
www.medicinesauthority.gov.mt/adrportal.
4.9
OVERDOSE
Overdose is considered unlikely with this product. However, if large
quantities have
been ingested, vomiting, inflammation of mucous membranes of the mouth
and
stomach, weakness, mental confusion, cold sweats, depression of pulse
and leg
cramps may occur.
Where phenol has been swallowed it may be necessa