Summary of Product Characteristics (SmPC) - Nix 98.66% w/w Styptic Pencil, Boots 98.66% w/w Styptic Pencil, Murrays 98.66% w/w Styptic Pencil
1 NAME OF THE MEDICINAL PRODUCT
Nix 98.66% w/w Styptic pencil
Boots 98.66 % w/w Styptic Pencil
Murrays 98.66% w/w Styptic Pencil
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aluminium sulphate. (Active) 98.66% w/w
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous Stick
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Used as a haemostatic for superficial wounds and abrasions Relief of discomfort of insect bites and stings
4.2 Posology and method of administration
Moisten end of the pencil with water. Administered topically by direct application to the wound or sting. Dry pencil after use.
For topical application only.
4.3 Contraindications
Hypersensitivity to aluminium sulphate or to any of the excipients
4.4 Special warnings and precautions for use
For topical application to skin only.
For use by one person only
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
None
4.7 Effects on ability to drive and use machines
Not relevant
4.8 Undesirable effects
None known
4.9 Overdose
None known
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Aluminium agents ATC code: D08AB Aluminium sulphate precipitates protein and is a powerful astringent
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
None
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Purified Talc 1.34% w/w
6.2 Incompatibilities
Not applicable
6.3 Shelf life
5 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Plastic holder and push-on cover.
Pack size 5g
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Bray Group Ltd
1 Regal Way
Faringdon
Oxfordshire SN7 7BX
8 MARKETING AUTHORISATION NUMBER
PL 04286/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29th September 1982 / 03rd February 1993
10 DATE OF REVISION OF THE TEXT
31/03/2010