Metanium Nappy Rash Ointment

1. Name Of The Medicinal Product

Metanium Ointment

Metanium Nappy Rash Ointment

2. Qualitative And Quantitative Composition

Titanium Dioxide	20.0% w/w
Titanium Peroxide	5.0% w/w
Titanium Salicylate	3.0% w/w

3. Pharmaceutical Form

Ointment for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

As a treatment for nappy rash

4.2 Posology And Method Of Administration

Posology:

Topical.

Adults:

Not applicable.

Elderly:

Not applicable.

Children:

Dab a small amount of Metanium over the sore area. Spread the ointment thinly so the skin texture can be clearly seen through it. Repeat at each nappy change.

4.3 Contraindications

Hypersensitivity to the drug formulation.

4.4 Special Warnings And Precautions For Use

If no response occurs, or the condition worsens, consult your doctor.

For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not known.

4.6 Pregnancy And Lactation

Not known.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Rarely: skin irritations.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of titanium salts with a water repellent siliconised base forms a tenacious non-occlusive film on the skin which protects against irritation and repeated hydration.

5.2 Pharmacokinetic Properties

Metanium is indicated for topical use and has an action similar to zinc oxide preparations.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dimethicone 350

Light Liquid Paraffin

Tincture of Benzoin

White Soft Paraffin.

6.2 Incompatibilities

Not known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium collapsible tube with membrane seal and spiked polypropylene cap.

Pack sizes: 25 g, 30 g.

6.6 Special Precautions For Disposal And Other Handling

No special precautions necessary.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0366

9. Date Of First Authorisation/Renewal Of The Authorisation

30/04/02.

10. Date Of Revision Of The Text

8^th April 2010