Mentholatum Vapour Rub

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methyl salicylate; Menthol; Racemic camphor

Available from:

The Mentholatum Company Ltd

INN (International Name):

Methyl salicylate; Menthol; Racemic camphor

Dosage:

3.3mg/1gram ; 13.5mg/1gram ; 90mg/1gram

Pharmaceutical form:

Inhalation vapour ointment

Administration route:

Cutaneous; Inhalation

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: ; GTIN: 05011501020010

Patient Information leaflet

-
MENTHOLATUM BALM
(menthol, camphor & methyl salicylate ointment)
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 Mentholatum
Balm 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 see a doctor if your symptoms do not get better.
•
If any of the side effects gets serious or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Mentholatum Balm is and what it is used for.
2. Before you use Mentholatum Balm.
3. How to use Mentholatum Balm.
4. Possible side effects.
5. How to store Mentholatum Balm.
6. Further information.
SECTION1. WHAT MENTHOLATUM BALM IS AND WHAT IT IS USED FOR
Mentholatum Balm is an ointment for use on the skin or for inhalation
to ease congestion. It is
recommended for the relief of symptoms of:
•
colds, congestion (catarrh) and hay fever
•
muscular pain and stiffness including:
o
backache and lumbago (lower back pain)
o
sciatica (pain in the lower back and thigh)
o
fibrositis (muscle tenderness or stiffness)
o
rheumatic pain (in muscles, tendons or joints)
o
bruises
o
chilblains
•
minor skin conditions including:
o
dry and chapped skin
o
nettle rash
o
insect bites and stings
o
itching.
2. BEFORE YOU USE MENTHOLATUM BALM.
Do not use if you have:
•
an allergy to any of the ingredients
in Mentholatum Balm (see Section 6)
•
an allergy to painkillers such as aspirin, ibuprofen and other
non-steroidal anti-
inflammatory drugs (NSAIDs).
•
broken or delicate skin.
Do not use on:
•
children under 3 year old
•
your eyes or other sensitive areas. If this happens wash with plenty
of clean water.
Mentholatum Balm is only for use on the skin or by inhalation. Do not
take by mouth.
Take care that the rub cannot be licked off by a child after it is
applied.
TAKE SPECIAL CARE
See your do

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mentholatum Balm or
Mentholatum Vapour Rub
Lloydspharmacy Vapour Rub
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl salicylate
0.33% w/w
Menthol
1.35% w/w
Camphor
9.00% w/w
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment for topical application to the skin or inhalation.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of:
i)
colds, catarrh and hay fever
ii)
muscular pain and stiffness, including backache, sciatica, lumbago,
fibrositis, rheumatic pain, bruises and chilblains.
iii)
minor skin conditions (including dry and chapped skin, nettle rash,
insect
bites and stings, itching).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For adults and children over 3 years
To be applied 2-3 times daily
Directions for use: -
i)
Allow inhalation of the vapour following either (a) rubbing onto the
chest,
neck and back, or (b) melting one teaspoonful in hot water.
ii)
Rub onto the affected area
iii)
Dab a small amount lightly onto the affected skin.
Do not apply under the nostrils in children.
4.3.
CONTRAINDICATIONS
Hypersensitivity to any of the components of the formulation.
Hypersensitivity
to aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs
(including
when taken by mouth), especially where associated with a history of
asthma.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use and only on unbroken skin. The product should not be
applied
to delicate skin.
Asthma – caution is required as salicylates may provoke bronchospasm
in
patients with asthma (see section 4.3).
Pregnancy and breast feeding – avoid use unless necessary (see
section 4.6)
Interactions – salicylates can increase the effect of anticoagulants
and
antiplatelet medications (see section 4.5).
Avoid contact with the eyes and sensitive areas of skin.
Always try on a small
area first.
Wash hands immediately after use. Discontinue use if excessive
irritation or other unwanted effects occur. If symptoms persi