Germolene antiseptic ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zinc oxide; Octafonium chloride; Phenol; Methyl salicylate; Wool fat; Starch; Liquid paraffin light; White soft paraffin; Yellow soft paraffin

Available from:

Bayer Plc

ATC code:

n/a

INN (International Name):

Zinc oxide; Octafonium chloride; Phenol; Methyl salicylate; Wool fat; Starch; Liquid paraffin light; White soft paraffin; Yellow soft paraffin

Dosage:

65.5mg/1gram ; 3mg/1gram ; 11.9mg/1gram ; 30mg/1gram ; 350mg/1gram ; 100mg/1gram ; 79mg/1gram ; 11.3mg/1gram ; 348mg/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 13100500; GTIN: 5010605829031

Patient Information leaflet

BAYER PLC
BAYER HOUSE
STRAWBERRY HILL
NEWBURY
BERKSHIRE RG14 1JA
UNITED KINGDOM
TELEPHONE:
[phone]
FACSIMILE:
[phone]
COMPANY WEB SITE:
HTTP://WWW.BAYER.CO.UK
Due to regulatory changes, the content of the following Patient
Information
Leaflet may vary from the one found in your medicine pack. Please
compare the 'Leaflet prepared/revised date' towards the end of the
leaflet
to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ANTISEPTIC OINTMENT_
PHENOL, ZINC OXIDE, METHYL SALICYLATE, OCTAFONIUM CHLORIDE
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
Germolene Antiseptic 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 you have any unusual effects after
using this product, tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What is Germolene Antiseptic Ointment
and what is it used for?
2.
Before you use Germolene Antiseptic
Ointment
3.
How to use Germolene Antiseptic
Ointment
4.
Possible side effects
5.
How to store Germolene Antiseptic
Ointment
6.
Further information
1.WHAT IS GERMOLENE
®
ANTISEPTIC OINTMENT
AND WHAT IS IT USED FOR?
Germolene Antiseptic Ointment is used to
treat minor cuts and grazes, minor burns,
scalds, blisters, sore and rough skin, washday
hands, sunburn or stiff aching muscles.
The ointment contains four active
substances. Phenol and octafonium chloride
have antiseptic properties for the
disinfection of skin, wounds and burns.
Phenol also has a local anaesthetic action for
the relief of pain. Methyl salicylate relieves
inflammation and pain. Zinc oxide is a mild
astringent (helps to reduce bleeding).
The
ointment base helps soften the skin and
soothe irritation.
2

Summary of Product characteristics

OBJECT 1
GERMOLENE ANTISEPTIC OINTMENT
Summary of Product Characteristics Updated 21-Sep-2011 | Bayer plc
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6. Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
Administrative data
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Germolene Antiseptic Ointment
2. Qualitative and quantitative composition
Zinc Oxide Ph. Eur. 6.55%, Methyl Salicylate Ph. Eur. 3%, Phenol Ph.
Eur. 1.19% and Octafonium
Chloride 0.3%.
3. Pharmaceutical form
Ointment for topical administration.
4. Clinical particulars
4.1 Therapeutic indications
For minor cuts and grazes, minor burns and scalds and blisters, sore
or rough skin, wash-day hands,
sunburn and the symptomatic relief of muscular pain and stiffness.
4.2 Posology and method of administration
_Minor cuts and grazes etc.:_ Clean the wound and apply directly or on
a dressing.
_Minor burns, scalds and blisters:_ Apply liberally and cover with a
light bandage.
_Sore, rough skin, wash-day hands_, _sunburn etc.:_ Apply directly and
rub in gently.
_Stiff, aching muscles:_ Apply liberally and massage in tho