Hydrogen Peroxide Solution 9% w/v (30 Vols)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROGEN PEROXIDE

Available from:

LCM Limited Linthwaite Laboratories, Huddersfield, HD7 5QH, United Kingdom

ATC code:

D08AX01

INN (International Name):

HYDROGEN PEROXIDE 22.5 % (V/V)

Pharmaceutical form:

SOLUTION

Composition:

HYDROGEN PEROXIDE 22.5 % (V/V)

Prescription type:

OTC

Therapeutic area:

ANTISEPTICS AND DISINFECTANTS

Authorization status:

Withdrawn

Authorization date:

2006-10-31

Patient Information leaflet

CARRIER:
FRONT FACE:
FRONT FACE REVERSE:
65MM X 170MM MULTIPEEL WITH 50MM HINGE LEFT
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MHRA HEADER BOX
PRODUCT TITLE
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Landscape peelable label
200ml
23744009
65 x 170mm
1
19.09.2017
Hydrogen Peroxide Solution 9% 30 vols
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6.6pt
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POINT SIZES USED
MIN MAX
_HYDROGEN_
_PEROXIDE_
_SOLUTION 9%_
_30 VOLS_
FOR EXTERNAL USE ONLY
FOR USE AS A MILD SKIN DISINFECTANT,
MOUTHWASH OR GARGLE
200ML
PEEL
HERE
IMPORTANT: PEEL THIS LABEL
AT CORNER AND READ BEFORE
USE. DO NOT TEAR OFF, RE-FIX FOR
FUTURE USE.
For use as a mild disinfectant for minor
cuts, wounds and skin ulcers or as a
mouthwash and gargle.
FOR SKIN DISINFECTION:
ADULTS, THE ELDERLY AND CHILDREN:
• Dilute a portion of the peroxide with an
equal amount of water.
• Soak some cotton wool in this solution and
use it to dress the wound as required.
AS A MOUTHWASH OR GARGLE:
ADULTS, THE ELDERLY AND CHILDREN OVER 12
YEARS:
• Dilute a portion of the peroxide with eight
times the amount of water e.g. 5ml of
peroxide and 40ml of water.
• Use this solution to rinse the mouth for
2 – 3 minutes.
• Repeat up to three times a day.
DO NOT GIVE TO CHILDREN UNDER 12
YEARS OLD AS A MOUTHWASH unless
your doctor tells you to.
PEEL WHERE SHOWN FOR FURTHER
PRECAUTIONS.
ACTIVE INGREDIENT: hydrogen peroxide 9% w/v.
ALSO CONTAINS: phosphoric acid (E338),
phenacetin and purified water.
Do not store above 25°C. Protect from light.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Manufactured by the licence holder
L.C.M. Ltd., Huddersfield, HD7 5QH, UK for
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.
MA213/00702 PL 12965/0017
PIP: 108-6677 23744009
This medicine contains hydrogen peroxide, a
disinfectant and deodorant. It kills bacteria by
releasing oxygen when in contact with body
tissues.
1.
BEF

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrogen Peroxide Solution 9% 30 Vols
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrogen peroxide aqueous solution 35% w/w HSE 22.5% v/v.
3
PHARMACEUTICAL FORM
Solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1. As a mild disinfectant for minor cuts, wounds and skin ulcers.
2. As a mouthwash or gargle.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Topical.
1.
As a disinfectant:
Use as required. Dress the wound with cotton wool soaked in a solution
of equal parts of
peroxide and water.
As a disinfectant this product is suitable for use by adults, children
and the elderly.
2.
As a mouthwash or gargle:
Dilute one part of peroxide to eight parts of water. Rinse the mouth
for two to three minutes.
This may be repeated up to three times daily.
As a mouthwash or gargle the product is suitable for use by adults,
children over 12 years and
the elderly. Due to the risk of swallowing it should only be used by
younger children under the
instruction of a doctor.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients
Not for use in closed body cavities or on surgical wounds due to the
risk of oxygen
released into the circulation causing gas embolism.
Not for use as a disinfection agent for surgical instruments
(particularly endoscopes)
and as an enema.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
For external use only.
Keep all medicines away from children.
Not for use in closed body cavities or on surgical wounds due to risk
of oxygen
released into the circulation causing gas embolism.
Avoid normal skin.
Product bleaches fabric.
4.5
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
None known.
4.6
PREGNANCY AND LACTATION
All medicines should be avoided if possible during pregnancy and
lactation. No
evidence is available as to the safety of use of this product in these
conditions.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8
UNDESIRABLE EFFECTS
Cases of gas embolism, sometimes resulting in cardiac