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Oilatum Junior Flare-Up

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Document: label-leaflet MAH BRAND2_PL 00079-0710 change

500 ml Label

Front

Oilatum® Junior Flare-up

light liquid paraffin benzalkonium chloride triclosan

Antiseptic bath emollient for the topical treatment of eczema

Stiefel Logo

Back

Bath Additive

Please read the information on the outer carton before using this product.

DIRECTIONS

Always dilute with water before use.

For adults, elderly and children over 2 years:

In an 8 inch (20 cm) bath, add 2 capfuls (20 ml).

In a 4 inch (10 cm) bath, add 1 capful (10 ml).

Infants over 6 months:

Add 1 ml (just enough to cover the bottom of the cap) to the bath water and mix well. Not recommended for babies less than 6 months.

Soak the affected areas of skin for 10 - 15 minutes. Gently pat dry.

Oilatum Junior Flare-up is an effective cleanser and should not be used with soap.

If you accidentally swallow the undiluted product it can cause an upset stomach, sickness and may burn and damage your throat. Contact your doctor for advice if you feel unwell.

CAUTION

Do not use Oilatum Junior Flare-up if you have previously had a skin reaction or allergy (hypersensitivity) to any of the ingredients (listed below).

Oilatum Junior Flare-up contains benzalkonium chloride, which is an irritant and may cause skin reactions.

Oilatum Junior Flare-up can make your bath slippery so be careful when getting into or out of the bath.

For external use only


Keep out of the reach and sight of children

Active ingredients (w/w basis): light liquid paraffin 52.5%, benzalkonium chloride 6.0%, triclosan 2.0%.

Other ingredients: acetylated lanolin alcohols, isopropyl palmitate, oleyl alcohol and macrogol lauryl ether.

Beecham Group plc 980 Great West Road Brentford, Middlesex TW8 9GS, United Kingdom

PL 00079/0710 MA 300/01004

Oilatum is a trademark © 2012 Stiefel Laboratories, Inc

Lot EXP    500 ml

500 ml Carton label/leaflet Front of carton

Oilatum® Junior Flare-up light liquid paraffin benzalkonium chloride triclosan

Antiseptic bath emollient for the topical treatment of eczema

Stiefel Logo

(Oilatum Junior Flare-up - name in Braille)

Back of pack Bath Additive

Oilatum Junior Flare-up is used to treat eczema that is at risk of becoming infected.

Oilatum Junior Flare-up is for use by adults, children and babies over 6 months old.

Do not use Oilatum Junior Flare-up if you have previously had a skin reaction or allergy (hypersensitivity) to any of the ingredients (listed below).

DIRECTIONS

Always dilute with water before use.

Use once daily, do not exceed the recommended amount.

For adults, elderly and children over 2 years:

In an 8 inch (20 cm) bath, add 2 capfuls (20 ml).

In a 4 inch (10 cm) bath, add 1 capful (10 ml).

Infants over 6 months:

Add 1 ml (just enough to cover the bottom of the cap) to a baby bath containing approximately 15 litres of water and mix well. Not recommended for babies less than 6 months.

Soak the affected areas of skin for 10 - 15 minutes. Gently pat dry.

Oilatum Junior Flare-up is an effective cleanser and should not be used with soap.

When you have finished your bath, rinse the waste pipe with additional warm running water. This will ensure there is no residue left in the drain pipe. It may also be necessary to clean the bath with a degreasing agent.

If you accidentally swallow the undiluted product it can cause an upset stomach, sickness and may burn and damage your throat. Contact your doctor for advice if you feel unwell.

CAUTION

Oilatum Junior Flare-up contains benzalkonium chloride, which is an irritant and may cause skin reactions.

Undiluted Oilatum Junior Flare-up can cause irritation, so avoid getting it on your skin or in your eyes. If you get Oilatum Junior Flare-up in your eyes, rinse at once with plenty of water for 15 minutes. If there is persistent eye irritation seek medical advice taking this bottle with you. If you get skin irritation, contact your doctor or pharmacist.

Oilatum Junior Flare-up can make your bath slippery so be careful when getting into or out of the bath.

Talk to your doctor if you are pregnant or breast-feeding. Wash-off all traces of Oilatum Junior Flare-up from your breasts before you begin to breast-feed.

Possible side effects: skin reactions including peeling, redness, inflammation, itching and burning. Tell your doctor or pharmacist if any of the side effects listed becomes severe or troublesome, or if you notice any side effects not listed.

For external use only


Keep out of the reach and sight of children

Do not use the product after the expiry date.

ACTIVE INGREDIENTS

(w/w basis): light liquid paraffin 52.5%, benzalkonium chloride 6.0%, triclosan 2.0%.

OTHER INGREDIENTS

acetylated lanolin alcohols, isopropyl palmitate, oleyl alcohol and macrogol lauryl ether.

Oilatum Junior Flare-up does not contain perfume or colouring.

Side 1 of carton

Oilatum® Junior Flare-up

light liquid paraffin benzalkonium chloride triclosan

Barcode

Marketing Authorisation Holder: Beecham Group plc 980 Great West Road Brentford, Middlesex TW8 9GS, United Kingdom

Manufacturer:

Stiefel Laboratories (Ireland) Ltd., Finisklin Business Park, Sligo,

Ireland

PL 00079/0710 MA 300/01004

Date of information: February 2013

Side 2 of carton

Oilatum® Junior Flare-up

light liquid paraffin benzalkonium chloride triclosan

500 ml

Oilatum is a registered trademark of Stiefel Laboratories, Inc. © 2012 Stiefel Laboratories, Inc.

Top flap of carton

Oilatum® Junior Flare-up

light liquid paraffin benzalkonium chloride triclosan

Bottom flap of carton

Lot:    EXP:

Page 5

STIEFEL CONFIDENTIAL