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Antiseptic Liquid

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Document: label-leaflet MAH BRAND_PL 00030-0126 change

PARTICULARS TO APPEAR ON THE IMMEDIATE/OUTER PACKAGING Bottle


1. NAME OF THE MEDICINAL PRODUCT


Savlon Antiseptic Liquid

Cetrimide 3.0% w/v Chlorhexidine Gluconate 0.3% w/v


2. STATEMENT OF ACTIVE SUBSTANCE(S)


Active ingredients: Cetrimide 3.0% w/v and Chlorhexidine Gluconate 0.3% w/v.


3. LIST OF EXCIPIENTS_

Also contains: Isopropyl alcohol, terpineol, liquid deodoriser, benzyl benzoate, d-gluconolactone, sodium hydroxide and purified water.


4. PHARMACEUTICAL FORM AND CONTENTS

Liquid


5.    METHOD AND ROUTE(S) OF ADMINISTRATION


Directions for use:

For First Aid treatment - Apply the diluted liquid carefully to the affected area. Add 2 capfuls (30ml) of the liquid to % litre of warm water.

For personal hygiene and midwifery - Add 2 capfuls (30ml) of the liquid to % litre of warm water.

For bathing - For full benefit do not mix with soap or detergents. Add 5 capfuls (75ml) to bath water.


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

THE SIGHT AND REACH OF CHILDREN


Do not use undiluted on the skin.

Caution: Avoid contact with the eyes and ears. Treat any accidental splashes to the eyes by washing open eyes with water for at least ten minutes and seek medical advice. If accidentally swallowed wash out the mouth and drink plenty of water or milk. Consult your doctor and show this container.

Keep out of the reach and sight of children.

Do not use after the expiry date given.


7. OTHER SPECIAL WARNING(S), IF NECESSARY


Side effects: In rare cases, skin irritation may occur; stop using and seek medical advice. If symptoms persist, or any unwanted effects occur, seek medical advice.

Use with care in newborn babies, especially those born prematurely. Savlon Antiseptic Liquid may cause chemical skin burns.


8. EXPIRY DATE

EXP


9. SPECIAL STORAGE CONDITIONS

Do not store above 25 °C.


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

Novartis Consumer Health, Horsham,

RH12 5AB, UK.


12. MARKETING AUTHORISATION NUMBER(S)


PL00030/0126


13. BATCH NUMBER

LOT


14. GENERAL CLASSIFICATION FOR SUPPLY


GSL


15. INSTRUCTIONS ON USE


Directions for use:

For First Aid treatment - Apply the diluted liquid carefully to the affected area. Add 2 capfuls (30ml) of the liquid to % litre of warm water.

For personal hygiene and midwifery - Add 2 capfuls (30ml) of the liquid to % litre of warm water.

For bathing - For full benefit do not mix with soap or detergents. Add 5 capfuls (75ml) to bath water.


16. INFORMATION IN BRAILLE


Savlon Antiseptic Liquid


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