Pill Identifier App

CALAMINE AND GLYCERIN CREAM

Active substance: ZINC OXIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Calamine and Glycerin Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Zinc Oxide Ph Eur
Calamine BP
Glycerin Ph Eur

3

%w/w
5
15
5

PHARMACEUTICAL FORM
Cream

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of sunburn. windburn, rough, dry hands, chapped and tender skin
and for the relief of skin irritation.

4.2.

Posology and Method of Administration
For topical application
Adults and Children:
To be applied gently to the affected parts when required.

4.3.

Contra-indications
Hypersensitivity to any of the ingredients.

4.4.

Special Warnings and Precautions for Use

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 drug interactions known.
May mask x-ray pictures under certain circumstances.

4.6.

Pregnancy and Lactation
The safety of Calamine and Glycerin Cream during pregnancy and lactation
has not been established but its use 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
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. Zinc oxide has mild
astringent, soothing and protective qualities.
Glycerol has emollient properties.

5.2.

Pharmacokinetic Properties
Not available.

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 of Excipients
Polawax A31
Paraffin light liquid
Isopropyl myristate
Polysorbate 80
Bentonite
Sodium citrate gran
Water purified
Liquefied phenol

6.2.

Incompatibilities
None known.

6.3.

Shelf Life

36 months.

6.4.

Special Precautions for Storage
None.

6.5

Nature and contents of container
An internally lacquered collapsible tube with latex welt having a
polypropylene or polythene cap, in a cardboard carton.
Pack size: 35 gm.

6.6.

Instruction for Use/Handling
None stated.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA

8.

MARKETING AUTHORISATION NUMBER
PL 00014/5129R

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
Date of First Authorisation: 9 November 1984
Last Renewal: 22 December 1994

10

DATE OF REVISION OF THE TEXT
January 2015

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)