BETADINE SKIN CLEANSER

Active substance: POVIDONE-IODINE

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Betadine Skin Cleanser

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone-iodine USP 4.00 % w/v

3

PHARMACEUTICAL FORM
Topical Aqueous solution

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Acne vulgaris of face and neck. For general disaffection of the skin (as a
liquid soap).

4.2

Posology and method of administration
Route of administration: Topical
ADULTS AND ELDERLY
Apply directly or with moistened sponge to the affected areas and work up a
rich lather. Allow to remain on the skin for 3 to 5 minutes then rinse off
thoroughly with warm water and dry with a clean or sterile towel or gauze.
Repeat twice daily.
CHILDREN (OVER 2 YEARS)
Apply as for adults and elderly.
INFANTS (UNDER 2 YEARS)
Limit use to 2 - 3 days.

4.3

Contraindications
Hypersensitivity to iodine, history of abnormal thyroid function or goitre.

4.4

Special warnings and precautions for use
Use on unbroken skin; as iodine is absorbed through burns and broken skin
and to a lesser extent, through intact skin. Restrict use in infants to 2-3 days.

4.5

Interaction with other medicinal products and other forms of interaction
None known.

4.6

Fertility, Pregnancy and lactation
Use in pregnancy and lactation should be limited and although no adverse
effects are anticipated from such limited usage, caution is recommended and
the therapeutic benefit must be balanced against the possible effect of the
absorption of Iodine on Foetal Thyroid Function.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
If local irritation or sensitivity develops, then discontinue treatment.

4.9

Overdose
Treatment
In the case of deliberate or accidental ingestion of large quantities,
symptomatic and supportive treatment should be provided with special
attention to electrolyte balance, thyroid and renal function.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Betadine skin cleanser solution contains povidone-iodine, a complex of iodine
which shows all the broad spectrum germicidal activity of elemental iodine.
The germicidal activity is maintained in the presence of exfoliative debris and
infected lesions whilst the colour persists. Betadine skin cleanser solution
kills bacteria, vimses, fungi, spores and protozoa.

5.2

Pharmacokinetic properties
The product is intended for topical application.

5.3

Preclinical safety data
Not Applicable

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Purified Water PH. EUR
Potassium Iodate
N.P.P.E. Ester
Lauric Diethanolamide
Hydroxyethyl Cellulose PH. EUR
Vah Floral Perfume No 2
Sodium Hydroxide BP

6.2

Incompatibilities
None known.

6.3

Shelf life
36 Months

6.4

Special precautions for storage
Store at temperature not exceeding 25 degrees Celsius.

6.5

Nature and contents of container
Polypropylene container with polypropylene lid containing 250ml.

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road,
Astmoor Industrial Estate,
Runcorn,
Cheshire,
WA7 1NU,
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 16431/0194

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14th March 2005

10

DATE OF REVISION OF THE TEXT
28/06/2012

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)