Internally approved for BCM postcode update (22/04/15) 3311b.doc Page 1

Label/leaflet for Dual Action Athlete’s Foot Powder (Proposed Wording to MHRA)

{Top Label}

Dual Action Athlete’s Foot Powder (Chlorhexidine Hydrochloride, Tolnaftate)

Please read this label carefully. It contains important information for you.

S How to use this medicine

•    Wash and thoroughly dry the affected area

•    Apply the powder liberally to the affected area

•    If suffering from athlete’s foot, apply the powder between the toes and also dust socks and inside of shoes with powder

Adults and children: Apply morning and night.

Continue treatment for at least one week after the condition has cleared up, to stop it coming back.

If you are treating athlete’s foot it is recommended that an athlete’s foot cream is used together with this product.

For use on the skin only.

Active ingredients

This powder contains Chlorhexidine Hydrochloride 0.25% w/w, Tolnaftate 1% w/w.

Also contains: purified talc, maize starch, colloidal silicon dioxide.

{INNER LABEL}

Please read this label carefully. It contains important information for you.

•    Keep this label you may need to read it again

•    Ask your pharmacist if you need more information or advice

What this medicine is for

An anti-fungal and antibacterial powder for the treatment and prevention of athlete’s foot. Also effective for other skin conditions where tenderness and sweating cause skin irritation, such as dhobie itch (groin ringworm).

Before you use this medicine

X Do not use:

•    If you are allergic to chlorhexidine or tolnaftate or any of the ingredients (see "What is in this medicine”)

You can use this medicine if you are pregnant or breastfeeding.

Other important information

This medicine may in rare cases cause severe allergic reactions, leading to a drop in blood pressure and even to unconsciousness. Early symptoms of a severe allergic reaction may

Label/leaflet for Dual Action Athlete’s Foot Powder (Proposed Wording to MHRA) be a skin rash or asthma. If you notice these symptoms, stop using the powder and contact your doctor as soon as possible.

S How to use this medicine

•    Wash and thoroughly dry the affected area

•    Apply the powder liberally to the affected area

•    If suffering from athlete’s foot, apply the powder between the toes and also dust socks and inside of shoes with powder

Adults and children: Apply morning and night.

Continue treatment for at least one week after the condition has cleared up, to stop it coming back.

If you are treating athlete’s foot it is recommended that an athlete’s foot cream is used together with this product.

For use on the skin only.

Possible side effects

Most people will not have problems, but some may get some.

! If you get any of these serious side effects, stop using the powder. See a doctor at once:

•    Swelling of the face, neck, tongue or throat, a red, itchy, skin rash, difficulty breathing, feeling faint and dizzy (severe allergic reaction)

If you get any of the following side effects see your pharmacist or doctor:

•    Contact dermatitis (redness and swelling of the skin), eczema, hives

•    Skin irritation, blisters Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

What is in this medicine

This powder contains Chlorhexidine Hydrochloride 0.25% w/w, Tolnaftate 1% w/w.

Also contains: purified talc, maize starch, colloidal silicon dioxide.

This pack contains 75 g powder

Who makes this medicine

Manufactured by BCM Ltd Nottingham NG2 3AA for the MAH: The Boots Company PLC Nottingham NG2 3AA Leaflet prepared April 2015

If you would like any further information about this medicine please contact The Boots Company PLC Nottingham NG2 3AA

Component code

BRAILLE NAME

Dual Action Athlete’s Foot Powder

PACK MOCK UP BOX

Label/leaflet for Dual Action Athlete’s Foot Powder (Proposed Wording to MHRA)

Product Name: Dual Action Athlete’s Foot Powder Product Licence No: 00014/0456

Wording Ref: Internally Approved, Proposed wording to be sent to MHRA as a result of a complaint, V1, dated 31/07/2014, 3311b.doc Status: Internally Approved

Pack details: Pigmented plastic bottle with snap plastic cap Pack size: 75 g Version No: 1 Date: 22/04/15

Reason for change: Correction of BCM Ltd postcode to NG2 3AA