Dulbalm cream

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Ethyl nicotinate; Methyl nicotinate; Benzyl nicotinate; Hydroxyethyl salicylate; Capsicum oleoresin

Հասանելի է:

Norma Chemicals Ltd

ATC կոդը:

n/a

INN (Միջազգային անվանումը):

Ethyl nicotinate; Methyl nicotinate; Benzyl nicotinate; Hydroxyethyl salicylate; Capsicum oleoresin

Դոզան:

10mg/1gram ; 10mg/1gram ; 10mg/1gram ; 20mg/1gram ; 100microgram/1gram

Դեղագործական ձեւ:

Cutaneous cream

Կառավարման երթուղին:

Cutaneous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Never Valid To Prescribe As A VMP

Ապրանքի ամփոփագիր:

BNF: 10030200

Տեղեկատվական թերթիկ

Dulbalm Cream
_Please read this leaflet carefully before using this _
_medicine. If you have any questions or are not sure _
_about anything, ask your doctor or pharmacist. _
WHAT DOES THE CREAM CONTAIN?
Each 100g of cream contains Ethyl Nicotinate 1g, Methyl
Nicotinate BP 1g, Benzyl Nicotinate 1g, Glycol Salicylate
2g and Capsicum Oleoresin BPC 10mg.
In addition to the active ingredients the cream also
contains Emulsifying Wax, White Soft Paraffin,
Polysorbate 80, Cineole and Purified Water.
WHAT PACK SIZES ARE AVAILABLE?
Dulbalm Cream is available in 25g tubes.
HOW DOES THE CREAM WORK?
Dulbalm Cream is a topical analgesic cream. The active
ingredients exert a rubifacient (warming) action on the
skin.
WHO IS RESPONSIBLE FOR PLACING THE CREAM ON THE
MARKET?
The product licence holder is
Norma Chemicals Ltd
51-53 Stert Street, Abingdon, Oxfordshire
OX14 3JF, United Kingdom
Product licence number: PL 00386/5007R
WHO MANUFACTURES THE CREAM?
The cream is manufactured by: -
Thorpe Laboratories Ltd.,
Enterprise Road, Mablethorpe, Lincs. LN12 1NB
WHAT IS THE CREAM FOR?
The symptomatic relief of the pain and stiffness
associated with muscular rheumatism, lumbago,
sciatica, fibrositis, sprains and chilblains.
WHAT SHOULD I KNOW BEFORE I USE THE CREAM?

Dulbalm Cream is for external use only.

Do not apply to broken or tender skin.

Keep away from eyes.

Do not use the cream if you know or suspect that
you are hypersensitive or allergic to any of the
ingredients.

Wash hands after use.

Do not apply to children under 6 years of age.

If you are pregnant or breast feeding, consult your
doctor or pharmacist before using this cream as it is
generally best not to use medicines at this time.
HOW DO I USE THE CREAM?
Do not apply near to eyes, nose, mouth, anal and
urinary areas. Discontinue use if a rash develops. Do
not cover the treated area with dressings that prevent
the passage of air and/or water. Do not expose treated
areas to excessive amounts of sunlight.
WHAT IS THE DOSE?
Apply with gentle massage

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dulbalm Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ethyl Nicotinate
1%
Methyl Nicotinate BP
1%
Benzyl Nicotinate
1%
Glycol Salicylate
2%
Oleoresin Capsicum BPC 1973
0.01%
3.
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
External application for the symptomatic treatment of muscle
stiffness,
muscular rheumatism, lumbago, sciatica, fibrositis, sprains and
chilblains.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Apply externally with gentle massage 2 - 3 times daily, avoiding
broken or
inflamed skin.
DO NOT APPLY TO CHILDREN UNDER 6 YEARS OF AGE.
4.3.
CONTRA-INDICATIONS
Known sensitivity to any of the ingredients.
Do not apply to children less than six years old.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not apply to broken or tender skin.
Application on mucous membranes should be avoided.
Discontinue if rash develops.
Not for use with occlusive dressings.
Topical application may result in systemic effects, including asthma.
Patients should be advised against excessive exposure of areas treated
to
sunlight, in order to avoid possibility of photosensitivity.
Keep away from eyes.
Wash hands after use.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6.
PREGNANCY AND LACTATION
As with most medicines, use in pregnancy or breastfeeding should be
avoided.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8.
UNDESIRABLE EFFECTS
Photosensitivity and application site reactions.
4.9.
OVERDOSE
Not applicable.
5
PHARMACOLOGICAL PROPERTIES
5.1
PHARMACODYNAMIC PROPERTIES
All the active ingredients in Dulbalm Cream are topical vasodilators
with
rubifacient activity.
5.2.
PHARMACOKINETIC PROPERTIES
External application of Dulbalm Cream to intact skin results in
negligible
systemic absorption.
5.3.
PRECLINICAL SAFETY DATA
Not applicable.
6
PHARMACEUTICAL PARTICULARS
6.1
LIST OF EXCIPIENTS
Emulsifying Wax, White Soft Paraffin, Polysorbate 80, Cineole,
Purified Wate