Sprilon 12.5 % Zinc Oxide and 1.04 % Dimeticone Cutaneous Spray, Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dimeticone 350; Zinc oxide

Available from:

Ayrton Saunders (Ireland) Limited

ATC code:

D02AB

INN (International Name):

Dimeticone 350; Zinc oxide

Dosage:

12.5%w/w + 1.04 percent weight/weight

Pharmaceutical form:

Cutaneous spray, suspension

Therapeutic area:

Zinc products

Authorization status:

Not marketed

Authorization date:

1996-05-21

Patient Information leaflet

AYRTON SAUNDERS (IRELAND) LTD.
SPRILON
®
12.5%W/W / 1.04%W/W
CUTANEOUS SPRAY SUSPENSION
ZINC OXIDE / DIMETICONE
115G
NON-IRRITANT
PROTECTIVE
WATER-REPELLENT
SPRAY OINTMENT
PA22906/001/001
MA HOLDER:
Ayrton Saunders (Ireland) Limited, 8A Sandyford Business Centre,
Blackthorn Avenue,
Sandyford, Dublin 18, Ireland.
MANUFACTURER:
MIAS Pharma Limited, Suite 1, Stafford House, Strand Road,
Portmarnock,
Co. Dublin, Ireland.
Fire hazard. Do not smoke or go near naked flames; clothing & bedding
with this product dried on
them can catch fire easily.
® Registered trademark Ayrton Saunders Ltd.
1. WHAT SPRILON IS AND WHAT IT IS USED FOR
Sprilon contains Zinc Oxide and Dimeticone. Sprilon is used for the
prevention and treatment of
pressure sores, and skin damage from contact with body fluids, e. g.
around the perineum, fistulae,
colostomies, ileostomies, eczematous areas etc. It is also used for
the protection and treatment of
fissures and leg ulcers, and the protection of skin beneath plaster
casts.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SPRILON
DO NOT USE SPRILON AND TALK TO YOUR DOCTOR IF:
•
You are allergic to zinc oxide, dimeticone, wool fat or any of the
other ingredients.
•
You are sensitive to cetostearyl alcohol.
Cetostearyl alcohol and wool fat may cause local skin reactions (e.g.
contact dermatitis). Ask your
doctor for advice before taking any medicine if you are pregnant or
breast-feeding.
WARNINGS AND PRECAUTIONS
AVOID INHALATION OR CONTACT WITH THE EYES.
If condition is aggravated, discontinue use and consult
doctor. Do not smoke or go near naked flames - risk of severe burns.
Fabric (clothing, bedding,
dressings etc) that has been in contact with this product burns more
easily and is a serious fire hazard.
Washing clothing and bedding may reduce product build-up but not
totally remove it.
3. HOW TO USE SPRILON
FOR EXTERNAL USE ONLY.
Shake the can well. Hold the can 20cm (8”) away from the skin
surface, at a right angle. Gently press
the nozzle to apply a thin even layer. Two to three seconds of
sp

Summary of Product characteristics

Health Products Regulatory Authority
09 July 2021
CRN00C073
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sprilon 12.5 % Zinc Oxide and 1.04 % Dimeticone Cutaneous Spray,
Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc Oxide 12.5 % w/w
Dimeticone 350 1.04 % w/w
Excipients with known effect
Wool Fat 5.19 % w/w
Cetostearyl Alcohol 0.519 % w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Spray, Suspension.
White, water-repellant, viscous ointment suspended in a propellant.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and treatment of pressure sores, and skin damage
from contact with body fluids e.g. around the perineum,
fistulae, colostomies, ileostomies, eczematous areas etc.
Protection and treatment of fissures and leg ulcers.
Protection of skin beneath plaster casts.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Shake can well. Spray surfaces at right angles from a distance of 20
cm (8”). Two to three seconds should be sufficient for the
area the size of the buttocks. Sprilon can be re-applied as often as
necessary.
4.3 CONTRAINDICATIONS
Do not use on patients with known sensitivity to wool fats.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid inhalation or contact with the eyes. Keep out of the reach and
sight of children.
If condition is aggravated, discontinue use and consult the doctor.
Instruct patients not to smoke or go near naked flames – risk of
severe burns. Fabric (clothing, bedding, dressings etc.) that has
been in contact with this product burns more easily and is a serious
fire hazard.
Washing clothing and bedding may reduce product build-up but not
totally remove it.
This product contains wool fat and cetostearyl alcohol which may cause
local skin reactions (eg. contact dermatitis).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Other topical preparations may disrupt the Sprilon film.
Health Products Regulatory Authority
09 July 2021
CRN00C073
Page 2 of 3
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