Medication Guide App

AQUEOUS CREAM BP (HYDROUS EMULSIFYING OINTMENT)

Active substance: PARAFFIN SOFT WHITE

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Transcript
PARTICULARS TO APPEAR ON LABEL
BASE LABEL

1.

NAME OF THE MEDICINAL PRODUCT

Aqueous Cream BP
(Hydrous Emulsifying Ointment)
2.

STATEMENT OF ACTIVE SUBSTANCE(S)

This preparation contains: White Soft Paraffin BP 15.0% w/w and Liquid Paraffin BP 6.0% w/w.
3.

LIST OF EXCIPIENTS

Also includes: Emulsifying Wax BP, 2-Phenoxyethanol, Purified Water.
4.

PHARMACEUTICAL FORM AND CONTENTS

Container:
500 g
5.

METHOD AND ROUTE(S) OF ADMINISTRATION

HOW TO USE IT
AGE

DOSAGE

ADULTS, ELDERLY & CHILDREN

Apply sparingly to the affected area as and when required.
When used as a vehicle for other active ingredients, dosage is to
be as indicated by the dispensing pharmacist.

6.

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

Keep out of the reach and sight of children.
If this product comes into contact with dressings and clothing the fabric can be easily ignited with a naked
flame. You should keep away from fire when using this product.
7.

OTHER SPECIAL WARNING(S), IF NECESSARY

For external use only.
8.

EXPIRY DATE

EXP

1

9.

SPECIAL STORAGE CONDITIONS

Not applicable
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Not applicable
11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Not applicable
12.

MARKETING AUTHORISATION NUMBER(S)

PL 28444/0133
13.

BATCH NUMBER

BN
14.

GENERAL CLASSIFICATION FOR SUPPLY

Not applicable
15.

INSTRUCTIONS ON USE

Used as an emollient to soothe and soften dry skin.
For the relief of minor skin irritations and as a vehicle for active ingredients to be applied to the skin.
Do not use this product after its ‘EXP’ date.
Please read the Package Leaflet before use on the reverse of this label.
16.

INFORMATION IN BRAILLE

Aqueous Cream BP

2

PACKAGE LEAFLET: INFORMATION FOR THE USER
AQUEOUS CREAM BP
(HYDROUS EMULSIFYING OINTMENT)
(Paraffin Soft White and Paraffin Liquid)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Aqueous Cream BP
(Hydrous Emulsifying Ointment) carefully to get the best results from it.
-

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell
your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Aqueous Cream is and what it is used for
Before you give Aqueous Cream
How to give Aqueous Cream
Possible side effects
How to store Aqueous Cream
Further information
WHAT AQUEOUS CREAM IS AND WHAT IT IS USED FOR
The name of your medicine is Aqueous Cream BP. It contains the active ingredient paraffin soft
white and paraffin liquid.
It is used for the relief of minor skin irritations and as a vehicle for active ingredients to be applied to
the skin.

2.

BEFORE YOU USE AQUEOUS CREAM
Do not use Aqueous Cream if you are allergic (hypersensitive) to paraffin soft white and paraffin
liquid or to any of the other ingredients. See section 6.
Take special care with Aqueous Cream
If this product comes into contact with dressings and clothing the fabric can be easily ignited with a
naked flame. You should keep away from fire when using this product.
Taking other medicines
Please consult your pharmacist if you are taking or have taken recently taken any other medicines,
including medicines obtained without prescription. Aqueous Cream may react other medicines and
products.
Pregnancy and Breast-feeding
Aqueous Cream can be used during pregnancy and lactation. However, if you are pregnant, consult
your doctor or pharmacist before use.

3

3.

HOW TO USE AQUEOUS CREAM
Follow the directions on this package leaflet or pack carefully, and ask your pharmacist to explain
any part you do not understand. For external use only.
Use as an emollient
For Adults, the Elderly and Children:
Apply sparingly to the affected area as and when required.
Use as vehicle for other active ingredients
Dosage as indicated by the dispensing pharmacist.
If you accidentally swallow Aqueous Cream or use more than you should
Please consult your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS
Like all medicines, Aqueous Cream can cause side effects, although not everybody gets them.
Very serious side effects –if any of the following happens, stop using Aqueous Cream and tell your
doctor immediately or go to the nearest hospital emergency department:



Allergic (hypersensitivity) reactions

If any of the side-effects gets serious or if you notice any side-effect not listed here, please tell your
doctor or pharmacist.
5.

HOW TO STORE AQUEOUS CREAM
Keep out of the reach and sight of children.
Keep the container tightly closed. Do not store above 25°C.
Do not use Aqueous Cream after the expiry date which is stated on the label. The expiry date refers to
the last day of that month.
Aqueous Cream should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of this product no longer required. These measures will help to protect the
environment.

6.

FURTHER INFORMATION
What Aqueous Cream contains
The active ingredients are Paraffin Soft White BP 15.0% w/w and Paraffin Liquid BP 6.0% w/w. The
other ingredients are 2-Phenoxyethanol and Emulsifying Wax.
What Aqueous Cream looks like and contents of the pack
Aqueous Cream is a homogenous white cream and comes in opaque container with lid in pack sizes
of 30g or 500g. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited, 11 Boumpoulinas, 3rd Floor, P.C. 1060, Nicosia, Cyprus.
Manufacturer
GlobeGen Laboratories Ltd.,1406 Coventry Road, South Yardley, Birmingham, B25 8AE, UK.
Date of last revision
September 2013

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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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