Betadine Skin Cleanser 40mg/ml cutaneous solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Povidone-iodine

Available from:

Mundipharma Pharmaceuticals Limited

ATC code:

D08AG; D08AG02

INN (International Name):

Povidone-iodine

Dosage:

40 milligram(s)/millilitre

Pharmaceutical form:

Cutaneous solution

Therapeutic area:

Iodine products; povidone-iodine

Authorization status:

Not marketed

Authorization date:

1975-11-25

Summary of Product characteristics

Health Products Regulatory Authority
09 July 2019
CRN0091J5
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Skin Cleanser 40mg/ml cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 40 mg povidone iodine.
For excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Solution.
Golden brown, clear viscous liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the disinfection and cleansing of skin in the management of
superficial infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply to thoroughly wet skin, then rinse, twice daily or as directed
by a physician.
4.3 CONTRAINDICATIONS
Use in patients with hypersensitivity to iodine.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use of the preparation may interfere with tests of thyroid function.
If there is aggravation of the condition or no improvement consult the
doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None stated.
4.6 FERTILITY, PREGNANCY AND LACTATION
Regular use of povidone-iodine should be avoided in pregnant or
lactating women as absorbed iodine can cross the placental
barrier and can be secreted into breast milk.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
Use of this preparation may interfere with tests of thyroid function.
4.9 OVERDOSE
Health Products Regulatory Authority
09 July 2019
CRN0091J5
Page 2 of 3
In the case of accidental ingestion of large quantities of Betadine,
symptomatic and supportive treatment should be provided
with special attention to electrolyte imbalance and renal and thyroid
function.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
D08AG02-Antiseptics and disinfectants
Betadine Skin Cleanser contains povidone-iodine, a complex of iodine
which shows all the broad spectrum germicidal activity
of elemental iodine.
5.2 PHARMACOKINETIC PROPERTIES
Not applicable.
5.3 PRECLINICAL SAFETY DATA
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Potass