Mentholatum Deep Heat Spray, cutaneous spray solution

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Ethyl salicylate; Hydroxyethyl Salicylate ; Methyl salicylate; Methyl nicotinate

Mevcut itibaren:

The Mentholatum Company (Ireland) Limited

ATC kodu:

M02AC

INN (International Adı):

Ethyl salicylate; Hydroxyethyl Salicylate ; Methyl salicylate; Methyl nicotinate

Farmasötik formu:

Cutaneous spray, solution

Terapötik alanı:

Preparations with salicylic acid derivatives

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

1993-10-18

Bilgilendirme broşürü

MENTHOLATUM DEEP HEAT SPRAY
®
CUTANEOUS SPRAY SOLUTION
FAST RELIEF FROM RHEUMATIC PAIN, MUSCULAR ACHES AND STRAINS
Deep Heat Spray is a pain relieving, warming spray to be used on the
skin. It is recommended for the
relief of pain in muscles, tendons, joints or bones, lower back and
thigh pain, sprains or strains. It can
be used before and after exercise.
DIRECTIONS FOR USE:
ADULTS AND CHILDREN OVER 5 YEARS ONLY.
•
Always try on a small area first and use sparingly.
•
Shake can well before use.
•
Hold the nozzle not less than 15cm (6”) from the site of pain and
spray in 2-3 short bursts. Massage
is not required. Protect the face when spraying around the
neck/shoulders.
•
Repeat up to 3 times per day.
•
Wash your hands after use.
•
Do not inhale.
CAUTION
:
DO NOT USE:
•
If you are allergic to any of the ingredients
•
If you are allergic to pain relievers such as aspirin, ibuprofen or
other anti-inflammatories.
•
On children under 5 years old
•
On broken skin, your eyes or other sensitive areas of skin
SEE YOUR DOCTOR BEFORE USE
: if you are
•
pregnant
•
breast feeding
•
asthmatic
•
taking medicines that thin the blood (e.g. warfarin), prevent clots
(e.g. aspirin) or any other
prescribed medicines
STOP USING if excessive irritation, allergic reaction or other
unwanted effects occur. Skin burns, blisters
and temporary skin redness, rashes or burning sensation may occur.
IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR.
Some people may experience discomfort, particularly those with
sensitive skin or if used in hot
weather/after a hot bath.
If you get any side effects talk to your doctor. You can also report
side effects at www.imb.ie.
FOR EXTERNAL USE ONLY
ACTIVE INGREDIENTS: (W/W)
Methyl nicotinate 1.6%, 2-hydroxyethyl salicylate 5.0%, Methyl
salicylate 1.0%, Ethyl salicylate 5.0%
Also contains: Isopropyl alcohol, Butane
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store below 30 °C.
Do not use after the expiry (EXP) date shown on the bottom of the can.
Ask your pharmacist how to
dispose of me

Ürün özellikleri

Health Products Regulatory Authority
01 September 2023
CRN00DMV5
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mentholatum Deep Heat Spray, cutaneous spray solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl Nicotinate
1.60
%w/w
2-Hydroxyethyl Salicylate
5.00
%w/w
Methyl Salicylate
1.00
%w/w
Ethyl Salicylate
5.00
%w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous spray, solution
Clear, colourless solution with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of muscular pain, bursitis and tendinitis,
including rheumatic pain, strains, sprains, fibrositis,
lumbago and sciatica.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children over 5 years of age:
Spray onto the parts affected when necessary, before or after
exercise.
Hold spray aperture about 15 centimetres (6 inches) from the skin of
the affected area. Spray in 2-3 short bursts up to 3 times
per day.
Children 5 years of age and under:
Not to be used on children under 5 years of age.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
Hypersensitivity to aspirin 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
Do not use if you are allergic to any of the ingredients or medicines
like aspirin.
Consult your doctor before use if you are pregnant, breast-feeding,
asthmatic or on any prescribed medicines.
For external use only. Not to be sprayed onto broken skin. Avoid
inhalation and contact with the eyes and sensitive areas of the
skin. Always try on a small area first. Always use sparingly since
some people may experience discomfort particularly those with
sensitive skin or if used in hot weather or after a bath.
Health Products Regulatory Authority
01 September 2023
CRN00DMV5
Page 2 of 4
Protect the face when spraying around the neck and shoulders.
Discontinue use if excessive irritation