Betadine Antiseptic Liquid 10% w/v

Betadine Antiseptic Liquid 10% w/v

povidone iodine

Manufacturer:

Mundipharma

Distributor:

DKSH
Full Prescribing Info
Contents
Povidone iodine.
Description
Active ingredient: Povidone-iodine 10% w/v.
BETADINE Antiseptic Liquid is formulated with 10%w/v povidone-iodine as a solution that kills 99.99% of germs* causing wound infection within 60 seconds.
* Kills gram-positive germs causing wound infection: S. aureus, S. pyogenes, S. epidermidis, S. haemolyticus, C. albicans, P. acnes.
Kills gram-negative germs causing wound infection: E. coli, P. aeruginosa, B. fragilis, K. pneumonia.
Excipients/Inactive Ingredients: Glycerol, Nonoxynol-9, Disodium Phosphate, Citric Acid, Sodium Hydroxide Potassium Iodate, Purified water.
Indications/Uses
BETADINE Antiseptic Liquid is indicated for: Management of minor wounds, including prevention of infection in burns, cuts, and abrasions.
Disinfection for hand hygiene including during periods of infectious disease outbreaks.
Disinfection of the skin before an operation.
Dosage/Direction for Use
For external use only.
Wounds, burns, cuts and abrasions: Apply the solution, undiluted, onto areas to be treated and allow to dry. Air-permeable film is formed which can be easily washed off with water. The solution can be applied several times daily, for maximum of 14 days.
Disinfection of the hands: Apply onto the palm and lather with hands and fingers for up to 1 minute. The natural golden brown colour of BETADINE Antiseptic Liquid easily identifies the areas that has been washed. Areas that are not golden brown in colour indicates further handwashing is required. Rinse thoroughly with water. BETADINE Antiseptic Liquid is not recommended for continuous daily use throughout the year.
Before surgery: Apply to all areas of skin with special attention to skin folds such as the arm pit, groin and anal area. Avoid pooling both under the patient and in the skin folds. Skin burns due to 'pooling' may occur.
Remove any jewelry before use especially silver articles.
BETADINE Antiseptic Liquid should not cover large areas of the skin (e.g. not to cover more than 10% of the total body surface) and for not longer than 14 days.
Contraindications
BETADINE Antiseptic Liquid should not be used if the patient: Has an allergy to iodine or any ingredients in the product; has a thyroid disorder; is pregnant or breast feeding or in children under 2 years of age unless advised by a healthcare professional; is using medications such as hydrogen peroxide, silver containing products, taurolidine or octenidine or mercury containing ingredients such as thiomersal.
Special Precautions
For external use only.
Consult a healthcare professional/hospital immediately if: Allergic reaction such as redness, irritation, swelling, itching, or severe rash.
Symptoms do not improve after 14 days or worsen.
Accidentally swallowed.
Use In Pregnancy & Lactation
BETADINE Antiseptic Liquid should not be used if patient is pregnant or breastfeeding.
Side Effects
Overactive thyroid symptoms may include feeling nervous, moody, difficulty in sleeping, trouble breathing, fast or irregular heartbeat, feeling hot and sweaty.
Increased amounts of acid in the blood (symptoms include shortness of breath, confusion and lethargy).
Kidney failure (symptoms include difficulty in urinating, thirst, dry mouth, and pain in one side of the back) have been reported with large amounts of BETADINE Antiseptic Liquid.
Ask a doctor or pharmacist for advice if the patient noticed any undesirable effects previously mentioned.
Storage
Store at or below 30°C. Do not store in a vehicle.
Shelf-life: 3 years from the date of manufacturing.
ATC Classification
D08AG02 - povidone-iodine ; Belongs to the class of iodine product antiseptics. Used in the treatment of dermatological diseases.
Presentation/Packing
Topical soln (bottle) (brown-coloured, which is free from suspended material or sedimentation) 10% w/v x 1's.
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