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Drug information

Boots Calamine+Glycerin

OTC
Read time: 2 mins
Last updated: 24 Mar 2015
...
 

Summary of product characteristics


1. Name of the medicinal product

Calamine and Glycerin Cream


2. Qualitative and quantitative composition

Active Ingredients% w/w
Zinc OxidePh Eur5
CalamineBP15
GlycerinPh Eur5


3. Pharmaceutical form

Cream


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 applicationAdults and Children: To be applied gently to the affected parts when required.


4.3. Contraindications

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. Fertility, 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 reactionsReporting 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.


5.1. 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.


6.1. List of excipients

Polawax A31 Paraffin light liquid Isopropyl myristate Polysorbate 80 Bentonite Sodium citrate gran Water purifiedLiquefied 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. Special precautions for disposal and other handling

None stated.


7. Marketing authorisation holder

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


8. Marketing authorisation number(s)

PL 00014/5129R


9. Date of first authorisation/renewal of the authorisation

Date of First Authorisation: 9 November 1984
Last Renewal:22 December 1994


10. Date of revision of the text

6 January 2015

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 applicationAdults and Children: To be applied gently to the affected parts when required.

4.3 Contraindications

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 Fertility, 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 reactionsReporting 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.

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The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.

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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).