WAXSOL docusate sodium 0.5% w/v ear drop liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

docusate sodium, Quantity: 5 mg/mL

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Ear Drops

Composition:

Excipient Ingredients: purified water; glycerol; methyl hydroxybenzoate; propyl hydroxybenzoate; phenoxyethanol; ethyl hydroxybenzoate; butyl hydroxybenzoate; isobutyl hydroxybenzoate

Administration route:

Otic

Units in package:

10mL bottle

Class:

Medicine Registered

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

For removal of ear wax

Product summary:

Visual Identification: Clear liquid; Container Type: Bottle; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-02

Patient Information leaflet

WAXSOL
® EAR DROPS
ACTIVE INGREDIENT: DOCUSATE SODIUM 0.5% W/V
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
WAXSOL. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING WAXSOL.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using WAXSOL?
2. What should I know before I use WAXSOL?
3. How do I use WAXSOL?
4. What should I know while using WAXSOL?
5. Are there any side effects?
6. Product details
1.
WHY AM I USING WAXSOL?
WAXSOL CONTAINS THE ACTIVE INGREDIENT DOCUSATE
SODIUM. WAXSOL IS USED TO HELP REMOVE EAR WAX IN
ADULTS, AND THE ELDERLY. Use in children under 12 years only
on medical advice. The drops help to clear your ear canal
if it is blocked with wax by softening it and breaking it up.
WAXSOL contains a mild emulsifier which penetrates and
helps disperse ear wax.
WHAT IS EAR WAX?
Ear wax is produced by the glands in the skin lining the ear
canal, and its purpose appears to be protective.
EAR CARE
The shape of the ear canal makes it difficult to clean.
Because of the delicate nature of the ear, cotton buds and
other instruments should never be inserted into it. WAXSOL
is used to soften and remove the ear wax.
2.
WHAT SHOULD I KNOW BEFORE I USE
WAXSOL?
WARNINGS
DO NOT USE WAXSOL IF:
•
you have hypersensitivity to the active substance, to any
of the excipients, or components that form the finished
product (see list in Section 6 Product Details).
Always check the ingredients to make sure you can use
this medicine.
•
you have a perforated ear drum (a hole in your eardrum)
•
your ear is sore or inflamed
During treatment, you may be at risk of developing certain
side effects. It is important you understand these risks and
how to monitor for them. See additional information under
Section 5. Are there any side effects?
PREGNANCY AND BREASTFEEDING
WAXSOL can be used if you are pregnant or breast-feeding.
3.
HOW DO I USE WAXSOL?
HOW MUCH TO USE
•
ALWAYS USE WAXSOL EXAC