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NELSONS CALENDULA CREAM

Active substance(s): CALENDULA OFFICINALIS TINCTURE 1/10

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Carton
1.

NAME OF THE MEDICINAL PRODUCT

Nelsons Calendula Cream
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each gram of cream contains: 9.0% v/w tincture of Calendula flowers
(Calendula officinalis L.) (1:10) Extraction solvent: Ethanol 0.3 % v/w

3.
LIST OF EXCIPIENTS
Purified water
Arlacel 170 (Glyceryl Stearate and PEG-100 Stearate)
Apricot kernel oil
Theobroma oil (Cocoa butter)
Glycerol
Polawax GP 200 (Cetearyl alcohol, PEG-20 Stearate)
Cetostearyl alcohol
Cetyl palmitate
Glyceryl monocaprylate
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Fragrance (Compo Cos: benzyl benzoate;propanol -oxybis; benzoate, 2,4-dihydro-3,6-dimethyl-, methyl; oils,
oakmoss-resinoid)
4.

PHARMACEUTICAL FORM AND CONTENTS

Cream
30g or 50g
5.

METHOD AND ROUTE(S) OF ADMINISTRATION

For topical use only
6.

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

Keep all medicines out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
If symptoms worsen or if signs of a skin infection are observed or if symptoms persist after using
the product for 1 week, a doctor or a qualified healthcare practitioner should be consulted.
.
Warnings: Do not use this product: if you are pregnant or breast feeding, if you are allergic to any of the ingredients
or to plants of the Asteracea (Compositae) family, if you are under 6 years of age
Important information about some of the ingredients.
Cetearyl alcohol may cause skin reactions (e.g. contact dermatitis).
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) in this medicine may cause
allergic reactions (possibly delayed).

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8.
EXPIRY DATE
EXP
Do not use after the expiry date
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

A Nelson & Co Limited
5-9 Endeavour Way
Wimbledon
London, England
SW19 8UH
12.

MARKETING AUTHORISATION NUMBER(S)

THR 01175/0400
13.

BATCH NUMBER

Lot No
14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product not subject to medical prescription.
15.

INSTRUCTIONS ON USE

Directions
Check that the tube seal is not broken before first use.
Pierce tube seal with point in top of cap before first use.
Wash hands before and after use.
Adults, the elderly and children over 6 years: Apply liberally to affected area 4 times a day as required.

Not recommended for use in children under 6 years of age.
16.

INFORMATION IN BRAILLE

NELSONS CALENDULA CREAM
17.

OTHERS

2

A traditional herbal medicinal product used for the symptomatic relief of sore and rough skin, based on
traditional use only.
Possible side effects: This product may cause skin sensitization.
If this or any other side effect occurs, consult your doctor or qualified healthcare practitioner
Making medicines safer:
You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at
www.mhra.gov.uk/yellowcar. Alternatively you can get a paper Yellow Card form from your doctor's surgery
or a pharmacyor call freephone 0808 100 3352 (available 10 am - 2 pm Monday to Friday )
THR Certification Mark
Natural care since 1860
Nelsons, the ellipse logo are trademarks or registered trademarks of A. Nelson & Co. group of companies.

3

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Tube
1.

NAME OF THE MEDICINAL PRODUCT

Nelsons Calendula Cream
2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Each gram of cream contains: 9.0% v/w tincture of Calendula flowers (Calendula officinalis L.) (1:10)
Extraction solvent: Ethanol 0.3 % v/v
3.

LIST OF EXCIPIENTS

Purified water
Arlacel 170 (Glyceryl Stearate and PEG-100 Stearate)
Apricot kernel oil
Theobroma oil (Cocoa butter)
Glycerol
Polawax GP 200 (Cetearyl alcohol, PEG-20 Stearate)
Cetostearyl alcohol
Cetyl palmitate
Glyceryl monocaprylate
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Fragrance NB01 (Alban Muller International, COMPO COS)
4.

PHARMACEUTICAL FORM AND CONTENTS

Cream
30g or 50g
5.

METHOD AND ROUTE(S) OF ADMINISTRATION

For topical use only
6.

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

Keep all medicines out of the sight and reach of children.
7.

OTHER SPECIAL WARNING(S), IF NECESSARY

If symptoms worsen or if signs of a skin infection are observed or if symptoms persist after using the product for
for 1 week, a doctor or a qualified healthcare practitioner should be consulted.
Warnings: Do not use this product: if you are pregnant or breast feeding, if you are allergic to any of the ingredients
or to plants of the Asteracea (Compositae) family, if you are under 6 years of age
Important information about some
of the ingredients.Cetearyl alcohol may cause skin reactions (e.g. contact dermatitis). Methyl parahydroxybenzoate
(E218) and propyl parahydroxybenzoate (E216) in this medicine may cause allergic reactions (possibly delayed).
8.
EXP

EXPIRY DATE
4

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

A Nelson & Co Limited
5-9 Endeavour Way
Wimbledon
London, England
SW19 8UH
12.

MARKETING AUTHORISATION NUMBER(S)

THR 01175/0400
13.

BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot No
14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product not subject to medical prescription.
15.

INSTRUCTIONS ON USE

Directions
Check that the tube seal is not broken before first use.
Pierce tube seal with point in top of cap before first use.
Wash hands before and after use.
Adults, the elderly and children over 6 years: Apply liberally to affected area 4 times a day as required.

16.

INFORMATION IN BRAILLE

17.

OTHERS

A traditional herbal medicinal product used for the symptomatic relief of sore and rough skin, based on
traditional use only.

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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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