Boots Ear Wax Remover
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Earex Ear Drops Boots Ear Wax Remover
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Almond oil 33.33%v/v
Arachis oil (peanut oil) 33.33%v/v
Rectified camphor oil 33.33%v/v
3 PHARMACEUTICAL FORM
Ear drops
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the easy removal of ear wax.
4.2 Posology and method of administration
Adults, children and the elderly:
1. Incline the head to one side.
2. Insert four drops with the applicator supplied.
3. Insert a piece of cotton wool.
4. Repeat night and morning for up to four days until wax is cleared. Route of administration: Installation into the ear.
Do not use if the ear is inflamed or infected. Do not use where the eardrum is not whole.
4.4 Special warnings and precautions for use
Never use force or instruments in the ear. Violent nose blowing should always be avoided. Wisdom or any decayed teeth should be examined in all cases of ear trouble.
Earex Ear Drops contain Arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Earex Ear Drops.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, Pregnancy and lactation
No special precautions.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
None stated.
Unlikely with this dosage form. Gastric lavage may be used in cases of accidental ingestion.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Not applicable.
6.2 Incompatibilities
None known.
6.3 Shelf life
24 months unopened. Upon opening an in-use shelf-life of 8 weeks.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Carton containing an amber glass bottle containing 10ml of product with a polypropylene/HDPE tamper evident closure, an acrylonitrile butadiene rubber teat and integral polypropylene dropper.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
G R Lane Health Products Ltd.
Sisson Road
Gloucester
GL2 0GR
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 01074/0242
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/12/1997
10
DATE OF REVISION OF THE TEXT
20/02/2015