Each gram of Betaiodine, 10% cream, contains:

active ingredient: povidone iodine – 100 mg;

excipients: ceteareth 12, ceteareth 20, cetostearyl alcohol, paraffin liquid, glycerin, sodium dibasic phosphate, citric acid, water purified.

2-Pyrrolidinone, 1-ethenyl-, homopolymer, compd. with iodine; 25655-41-8.

Antiseptic; D08AG02; G01AX11.

Betaiodine – povidone-iodine – is an iodophore that is used as a disinfectant and antiseptic mainly for the treatment of contaminated wounds and pre-operative preparation of the skin and mucous membranes as well as for the disinfection of equipment.

Iodophores are loose complexes of iodine and carrier polymers. Solutions of povidone-iodine gradually release iodine to exert an effect against bacteria, fungi, viruses, protozoa, cysts, and spores; povidone-iodine is thus less potent than preparations containing free iodine but it is less toxic.

Iodine is slightly absorbed when applied to the skin. When taken by mouth, iodine preparations (which are converted to iodide) are transported to, and concentrated in, the thyroid gland. Iodides not taken up by the thyroid are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva, and sweat. They cross the placenta and are distributed into breast milk.

• Treating minor wounds and infections, as well as killing bacteria.

Directions
Clean the affected area. Apply a small amount of Betaiodine Cream to the affected area.

Betaiodine can cause hypersensitivity reactions and irritation of the skin, although severe reactions are rare and povidone-iodine is considered to be less irritant than iodine.

The application of Betaiodine to severe burns or to large areas otherwise denuded of skin may produce the systemic adverse effects associated with iodine and metabolic acidosis, hypernatraemia, and renal impairment. Hyperthyroidism or hypothyroidism may occur after ingestion or absorption of large quantities. Hypothyroidism has occurred in neonates both as a result of absorption of iodine from Betaiodine applied to the neonate and also to the mother during pregnancy or breast feeding. Betaiodine application is contra-indicated in premature neonates or those weighing less than 1.5 kg.

Regular or prolonged use should be avoided in patients with thyroid disorders or those receiving lithium therapy.

• Broken skin; renal impairment.
• This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
  If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
• In severe renal impairment, avoid regular application to inflamed or broken skin or mucosa.
• The application of Betaiodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.
• Cream of iodine applied to the skin should not be covered with occlusive dressings. The disinfectant activity of iodine is reduced by alkalis as well as by protein.
• As povidone iodine can affect the thyroid gland, its use may interfere with tests of thyroid function.

Warnings

• For external use only!
• Do not use this product in the eyes!

Iodine is concentrated by the mammary gland into breast milk to ensure an adequate supply to the breast-fed infant. Second, third trimesters: sufficient iodine may be absorbed to affect the fetal thyroid.The BNFC (British National Formulary for Children) considers treatment with povidone-iodine to be a contra-indication to breast feeding.

• Preterm neonate gestational age under 32 weeks.
• Pregnancy, breast-feeding.
• Avoid regular use in patients with thyroid disorders or those receiving lithium therapy.
• Not for body cavity irrigation.

The effects of povidone-iodine on the thyroid may be altered by other compounds including amiodarone and lithium.

A brown colored cream having a characteristic iodine odor.

15 g and 20 g of cream is filled into aluminum tubes (inside package).
The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).

2 years.

Store in a cool and dry place, out of the reach of children. Protect from light.