Medicated Talc

1. Name Of The Medicinal Product

Medicated Talc

2. Qualitative And Quantitative Composition

Active ingredient%w/w

Allantoin 0.5%

3. Pharmaceutical Form

Powder

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of irritation in cases of chafing, heat rash and minor skin troubles.

4.2 Posology And Method Of Administration

For topical application to the skin.

Adults, elderly and children: After first washing and drying the affected parts, apply the powder liberally. Repeat as necessary.

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.

4.6 Pregnancy And Lactation

The safety of Medicated Talc 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

Rarely, hypersensitivity reactions may occur.

4.9 Overdose

It is unlikely that systemic toxicity will result from ingestion. In the event of large quantities of the product being swallowed, the stomach should be washed out and symptomatic and supportive measures applied.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Allantoin is claimed to stimulate tissue formation and hasten wound healing.

Talc has absorbent and antichafing properties and is used to allay skin irritation.

5.2 Pharmacokinetic Properties

None stated.

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

Maize starch powder

Sterilised pyrenean silk

Talc

Perfume comp 5380 narom

Waterlock A120

Industrial methylated spirit

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store in a dry place.

6.5 Nature And Contents Of Container

1. A high density polyethylene bottle with a low density polythene plug and a polypropylene cap with a fitted stearan BK-faced pulpboard liner.

Pack size: 110gm.

2. A polythene 'puffer' bottle fitted with a polythene rotex style closure.

Pack size: 100gm.

3. An HDPE bottle with a polythene rotex-type closure or a polypropylene flit-top cap.

Pack size: 100gm.

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 00014/5314R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 21 November 1989

Last Renewal: 10 February 1995

10. Date Of Revision Of The Text

October 1999