BETADINE SKIN CLEANSER
Active substance(s): POVIDONE-IODINE / POVIDONE-IODINE / POVIDONE-IODINE
NAME OF THE MEDICINAL PRODUCT
Betadine Skin Cleanser
QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone-iodine USP 4.00 % w/v
Topical Aqueous solution
Acne vulgaris of face and neck. For general disaffection of the skin (as a
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.
Hypersensitivity to iodine, history of abnormal thyroid function or goitre.
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.
Interaction with other medicinal products and other forms of interaction
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.
Effects on ability to drive and use machines
If local irritation or sensitivity develops, then discontinue 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.
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.
The product is intended for topical application.
Preclinical safety data
List of excipients
Purified Water PH. EUR
Hydroxyethyl Cellulose PH. EUR
Vah Floral Perfume No 2
Sodium Hydroxide BP
Special precautions for storage
Store at temperature not exceeding 25 degrees Celsius.
Nature and contents of container
Polypropylene container with polypropylene lid containing 250ml.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road,
Astmoor Industrial Estate,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
14th March 2005
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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