Deep Freeze Cold Gel 2.0 % w/w

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Racementhol

Disponible des:

The Mentholatum Company Ltd.

Codi ATC:

M02AX; M02AX10

Designació comuna internacional (DCI):

Racementhol

Dosis:

2.0 percent weight/weight

formulario farmacéutico:

Gel

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Other topical products for joint and muscular pain; various

Estat d'Autorització:

Not marketed

Data d'autorització:

1999-03-19

Informació per a l'usuari

140mm
184mm
Patient Information Leaflet
COLD GEL
2% W/W
Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription.
Nevertheless you still need to use Deep Freeze Cold
Gel 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
improve.
•
If any of the side effects become serious or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Deep Freeze Cold Gel is and what it is used
for
2.
Before you use Deep Freeze Cold Gel
3.
How to use Deep Freeze Cold Gel
4.
Possible side effects
5.
How to store Deep Freeze Cold Gel
6.
Further information 1.
WHAT DEEP FREEZE COLD GEL IS AND
WHAT IT IS USED FOR
Deep Freeze Cold Gel is a pain relieving gel to be
applied to the skin.
It is used for the relief of aches and pains of the:
•
muscles
•
tendons
•
joints 2. BEFORE YOU USE DEEP FREEZE COLD GEL
DO NOT USE DEEP FREEZE COLD GEL
IF YOU HAVE AN ALLERGY
•
to any of the INGREDIENTS
(see end of Section 2 and Section 6)
DO NOT USE DEEP FREEZE COLD GEL ON:
•
children under 5 years of age
•
your eyes or other sensitive areas. If this occurs
accidentally wash away with plenty of clean water
•
broken or inflamed skin.
Deep Freeze Cold Gel is only for use on the skin.
Do not take by mouth.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes any medicines you have bought without a
prescription.
PREGNANCY AND BREASTFEEDING
If you are pregnant or breast feeding ask your doctor
or pharmacist for advice before taking
any medicine.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF DEEP FREEZE COLD GEL
Deep Freeze Cold Gel contains:
•
METHYL HYDROXYBENZOATE (E218)
•
PROPYL HYDROXYBENZOATE (E216)
which may cause local allergic skin reactions (po

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Deep Freeze Cold Gel 2.0 % w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Racemic Menthol
2.0% w/w
Methyl parahydroxybenzoate (E218)
0.18% w/w
Propyl parahydroxybenzoate (E216)
0.02% w/w
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gel.
Smooth, clear, blue gel with odour of menthol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of pain in muscles, tendons and joints.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS (INCLUDING THE ELDERLY)_
Gently massage Deep Freeze Cold Gel into the affected area 3-4 times
daily
_CHILDREN (OVER FIVE YEARS)_
Apply to the affected area 3-4 times daily
_CHILDREN (UNDER FIVE YEARS)_
Not recommended
DIRECTIONS FOR USE
For topical application.
Apply over the affected area.
Massage gently until completely absorbed into the skin.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the components of the formulation.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_3_
_/_
_0_
_6_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_2_
_1_
_6_
_2_
_7_
_7_
_4_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep all medicines out of the sight and reach of children.
For external use only.
Hands should be washed immediately after use.
Avoid contact with eyes, mucous membranes and inflamed or broken skin.
Not for use with occlusive dressings.
May cause allergic reactions (possibly delayed).
Repeated app