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BOOTS DERMACARE ITCH RELIEF LOTION

Active substance(s): CROTAMITON / CROTAMITON / CROTAMITON

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Boots Derma Care Itch Relief Lotion– PL 44673/0114 – Label

PARTICULARS TO APPEAR ON THE INNER PACKAGING

TEXT ON LABEL

1.

NAME OF THE MEDICINAL PRODUCT

Boots Derma Care Itch Relief Lotion
Crotamiton

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Crotamiton 10% w/w

3.

LIST OF EXCIPIENTS

glycerol monostearate, sorbic acid, citric acid monohydrate, phenylethyl alcohol, propylene glycol,
perfume (containing benzyl benzoate), macrogol cetostearyl ether, 2-octyl dodecanol, cetostearyl alcohol
and purified water

4.

PHARMACEUTICAL FORM AND CONTENTS

100ml

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

For external use only

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. Do not use after the expiry date given.

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

Cautions: Do not use in or around the eyes, on broken skin, for weeping skin conditions or if you are
sensitive to any of the ingredients. Boots Derma Care Itch Relief Lotion is not recommended in
pregnancy. If you are breast feeding, or suffering from genital itching, Boots Derma Care Itch Relief
Lotion should only be used und the direction of your doctor.
May occasionally cause skin irritation or allergy. If this occurs or you experience other symptoms stop
using the product and consult your doctor. If Boots Derma Care Itch Relief Lotion is accidentally
swallowed, contact your nearest hospital casualty department or tell your doctor immediately
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

N/A

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
Brentford,

TW8 9GS,
U.K.

12.

MARKETING AUTHORISATION NUMBER(S)

PL 44673/0114

13.

BATCH NUMBER

LOT

14.

GENERAL CLASSIFICATION FOR SUPPLY

15.

INSTRUCTIONS ON USE

Stops itching fast
Works for up to 10 hours
A lotion for relief of itching and skin irritation caused by










Itchy dermatitis
Dry eczema
Allergic rashes
Chickenpox
Insect bites & stings
Hives, nettle rash
Sunburn
Heat rashes
Personal itching

Directions: Shake before use. Apply to the affected area 2-3 times daily. Irritation will be relieved for 6 to
10 hours. If symptoms persist consult your doctor.
Children: Boots Derma Care Itch Relief Lotion can be used for children. Consult your doctor before use
on children under 3 years of age.

16.

INFORMATION IN BRAILLE

Braill included on the outer carton.

Boots Derma Care Itch Relief Lotion– PL 44673/0114 – Carton

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

TEXT ON CARTON

1.

NAME OF THE MEDICINAL PRODUCT

Boots Derma Care Itch Relief Lotion
Crotamiton

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Crotamiton 10% w/w

3.

LIST OF EXCIPIENTS

glycerol monostearate, sorbic acid, citric acid monohydrate, phenylethyl alcohol, propylene glycol,
perfume (containing benzyl benzoate), macrogol cetostearyl ether, 2-octyl dodecanol, cetostearyl alcohol
and purified water

4.

PHARMACEUTICAL FORM AND CONTENTS

100ml

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

For external use only

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. Do not use after the expiry date given.

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

Do not use: in or around the eyes, on broken skin, for weeping skin conditions or if you are sensitive to
any of the ingredients.

Cautions: Boots Derma Care Itch Relief Lotion is not recommended in pregnancy. If you are breast
feeding, or suffering from genital itching, Boots Derma Care Itch Relief Lotion should only be used und
the direction of your doctor.
This product contains stearyl alchohol which may cause local skin reactions (e.g. contact dermatitis) and
methyl hydroxybenzoate why may cause allergic reactions (possibly delayed).
If Boots Derma Care Itch Relief Lotion is accidentally swallowed, contact your nearest hospital casualty
department or tell your doctor immediately
These ingredients: sorbic acid, propylene glycol, cetyl alcohol & stearyl alcohol may cause local skin
reactions.

8.

EXPIRY DATE

EXP

9.

SPECIAL STORAGE CONDITIONS

Do not store above 25 °C

10.

N/A

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

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

12.

MARKETING AUTHORISATION NUMBER(S)

PL 44673/0114

13.

BATCH NUMBER

LOT

14.

GENERAL CLASSIFICATION FOR SUPPLY

15.

INSTRUCTIONS ON USE

Effective relief of itching
Works for up to 10 hours
A lotion for relief of itching and skin irritation caused by










Itchy dermatitis
Dry eczema
Allergic rashes
Chickenpox
Insect bites & stings
Hives, nettle rash
Sunburn
Heat rashes
Personal itching

Directions: Shake before use. Apply to the affected area 2-3 times daily. Irritation will be relieved for 6
to 10 hours. If symptoms persist consult your doctor. Boots Derma Care Itch Relief Lotion can be used
for children.
Children under 3 years: Consult your doctor before use

16.

INFORMATION IN BRAILLE

Boots Derma Care Itch Relief Lotion

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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