This information is intended for use by health professionals

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 Pregnancy and lactation

The safety of Calamine Lotion during pregnancy and lactation has not been established but 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

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 of excipients

Bentonite

Glycerol

Sodium Citrate

Phenol

Water Purified

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

A white flint glass bottle with an unlined polypropylene cap.

An amber glass bottle with vinyl seal faced compocork in thermoset plastic cap.

Alternative cap: Aluminium roll-on pilfer-proof cap with a flowed in liner or a triseal (LDPE/EPE/LDPE) liner.

Pack sizes: 200, 2000 millilitres

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

Trading as: BCM

8. Marketing authorisation number(s)

PL 00014/5471R

9. Date of first authorisation/renewal of the authorisation

Date of First Authorisation:

31 October 1984

Date of Last Renewal:

23 January 1996

10. Date of revision of the text

16 December 2014