Home | About the eMC | Help | Mobile

eMC - trusted, up to date and comprehensive information about medicines

Search medicine/company name only

Search full document

Advanced search

Medicine name A-Z | Active ingredient A-Z | Pharmaceutical company A-Z | Latest medicine updates | Yellow card report

Thornton & Ross Ltd

Telephone: +44 (0)1484 842217
Fax: +44 (0)1484 847301
WWW: http://www.thorntonandross.com
Medical Information Direct Line: +44(0)1484 848 251

Medical Information e-mail: phv@thorntonross.co.uk
Customer Care direct line: +44(0)1484 842 217
Medical Information Fax: +44(0)1484 847 301

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 01/11/2011

SPC	Calamine Lotion BP

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
11. DOSIMETRY
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Calamine Lotion BP

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Calamine BP	15.0% w/v
Zinc Oxide BP	5.0% w/v

Go to top of the page

3. PHARMACEUTICAL FORM

Lotion

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

For relief of the symptoms of mild sunburn and other minor skin conditions.

Go to top of the page

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.

Go to top of the page

4.3 Contraindications

None known.

Go to top of the page

4.4 Special warnings and precautions for use

Shake the bottle.

For external use only.

Keep all medicines away from children

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

May mask x-ray pictures under certain circumstances.

Go to top of the page

4.6 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.

Go to top of the page

4.7 Effects on ability to drive and use machines

None known.

Go to top of the page

4.8 Undesirable effects

None known

Go to top of the page

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 necessary to empty the stomach by aspiration and lavage. Castor oil or olive oil may be added to the water to dissolve the phenol and delay absorption: 50ml of oil may be left in the stomach.

The patient should be kept warm, and pulmonary oedema, systemic acidosis, respiratory failure and circulatory failure should be treated symptomatically. Respiration may have to be assisted.

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

5.1 Pharmacodynamic properties

Calamine has a mild astringent action of the skin and is used as a dusting powder, cream, lotion or ointment in a variety of skin conditions.

Zinc oxide has a mildly antiseptic action and is a mild astringent, it has soothing and protective properties.

Go to top of the page

5.2 Pharmacokinetic properties

No information available.

Go to top of the page

5.3 Preclinical safety data

None.

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients

Bentonite BP, sodium citrate BP, glycerol BP, phenol BP and purified water BP.

Go to top of the page

6.2 Incompatibilities

None known.

Go to top of the page

6.3 Shelf life


100ml:	36 months unopened
200ml:	36 months unopened

Go to top of the page

6.4 Special precautions for storage

Store below 25°C.

Go to top of the page

6.5 Nature and contents of container

100ml:	Glass bottle with polypropylene cap or white 28mm cap with tamper evident band and EPE Saranex liner
200ml:	Glass bottle with polypropylene cap or white 28mm cap with tamper evident band and EPE Saranex liner

Go to top of the page

6.6 Special precautions for disposal and other handling

None.

Go to top of the page

7. MARKETING AUTHORISATION HOLDER

L.C.M. Ltd.,

Linthwaite Laboratories,

Huddersfield,

HD7 5QH,

England.

Go to top of the page

8. MARKETING AUTHORISATION NUMBER(S)