Savlon Dry Antiseptic

Document: label-leaflet MAH BRAND_PL 44673-0112 change

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

1. NAME OF THE MEDICINAL PRODUCT

Savlon Dry Antiseptic Povidone Iodine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Active ingredient: Povidone Iodine 1.14% w/w.

3. LIST OF EXCIPIENTS

Also contains: Povidone, n-pentane, soya lecithin, butane.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder Spray 50ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Savlon Dry Antiseptic is a fine antiseptic powder spray for no-touch first aid treatment. It forms a protective antiseptic layer that helps to prevent infection and aids natural healing in:

First aid • minor cuts, grazes and burns Sports • friction burns, blistered hands and feet Home • gardening and DIY abrasions.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Do not use: • Near eyes and nose • if sensitive to povidone iodine or any other ingredient. • If suffering from an overactive thyroid gland (increased appetite, weight loss or sweating). • on babies under 1 month of age • in deep wounds or clean surgical wounds with • other wound disinfectants and/or antiseptics • if on radioiodine therapy.

Consult your doctor before use: If suffering from kidney disease • if pregnant or breast-feeding • undergoing tests on urine or thyroid - this spray may affect the results • on lithium therapy. Do not use on large wounds or severe burns without a doctor’s advice. If symptoms persist consult your doctor.

Side-effects: Rarely causes local skin irritation and rash. Rarely hypersensitive (allergic) reactions may occur. Very rarely you may suffer from an overactive thyroid gland (Hyperthyroidism). STOP using and seek medical help immediately if you have any of the following very rare allergic reactions: difficulty breathing or swallowing. swelling of the mouth, face, lips, tongue or throat. severe itching of the skin, with a red rash or raised lumps, hives or blister. If you experience these or other side effects, stop using and seek medical advice. Prolonged use in patients with large wounds or severe/extensive burns may cause changes in blood electrolytes (e.g, increased sodium levels which would be found during blood tests) or reduce kidney function.

FOR EXTERNAL USE ONLY

EXTREMELY FLAMMABLE

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

PRESSURISED CONTAINER: Protect from sunlight.

DO NOT • expose to temperatures higher than 50°C • pierce or burn even after use • spray on naked flame or any flammable material • apply while you are smoking. Keep away from sources of ignition. Do not store above 25°C. Do not use after the expiry date.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

PL Holder: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.

Manufactured by: Pharmasol Ltd, North Way, Andover, SP10 5AZ, UK

Savlon is a registered trademark owned by or licensed to the GSK group of companies.

12. MARKETING AUTHORISATION NUMBER(S)

PL 44673/0112

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

Powder Spray

No-touch First Aid

Helps prevent infection

Aids natural healing

For minor cuts, grazes & burns

Directions: Shake before use and spray the affected area from a distance of 15-22cm (6-9”) to give a light dusting of powder. Do not use more than 1 can daily. If spray nozzle becomes blocked, remove, rinse in warm water and dry thoroughly.

Information prepared July 2016

16. INFORMATION IN BRAILLE

Savlon Dry