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BETADINE® Topical Preparations
Purdue Frederick
Povidone-Iodine
Antiseptic
 
Action And Clinical Pharmacology: Betadine is iodine complexed with povidone (polyvinyl-pyrrolidone). The compound is soluble in water forming a golden brown solution. Like iodine, the solution of the iodine complex is bactericidal, fungicidal, virucidal and trichomonacidal. However, unlike solutions of iodine, it is non-staining to natural fabrics. The antiseptic action of povidone-iodine is due to the available iodine present in the complex. tag_IndicationsIndications

Indications And Clinical Uses: Aerosol Spray: Prophylaxis or treatment of infection in minor wounds, burns and skin lesions. Skin preparation prior to surgery or injections.

Gauze Pads: For disinfection of wounds, cutaneous ulcers, lacerations, abrasions and first, second and third degree burns.

Mouth Wash/Gargle: As a mouth wash for routine use. Eliminates or reduces offensive mouth odors. As a gargle or mouth wash, as primary or adjunctive therapy in infections of the mouth and throat such as aphthous stomatitis, Vincent's infection, pharyngitis, oral moniliasis, tonsillitis, laryngitis, tongue ulcers, stomatitis, bronchitis, sinusitis and following oral surgery and dental procedures.

Ointment: For the prevention of infection in burns, cuts, abrasions, poison ivy rash, poison oak rash and insect bites. The treatment of skin infections, including infections of varicose and decubitus ulcers.

Shampoo: For seborrheic conditions of the scalp associated with erythema, scaling, exfoliation, pityriasis and pruritus. As a germicidal skin cleanser for prophylaxis of recurrent furunculosis and acute inflammatory skin lesions.

Skin Cleanser: Useful as a topical antimicrobial in preventing infections in lacerations, minor cuts, abrasions and burns caused by iodine-susceptible pathogenic organisms. Helps prevent acute and chronic inflammatory infections such as in acne vulgaris. In pyodermas, as a topical adjunct to systemic antimicrobial therapy. Prophylaxis of recurrent furunculosis and acute inflammatory skin lesions.

Solution: Use full strength for pre- and postoperative skin and mucous membrane antisepsis, prophylaxis and treatment of wounds, lacerations and burns, trichomonal, monilial and nonspecific vaginitis, cervicitis, oral infections, and dental procedures.

Surgical Scrub: Pre- and postoperative scrubbing or washing, pre- and postoperative use on patients, general use in physician's office.

Swab Aids: Disposable antiseptic germicide pad.

Precautions: Use with caution in patients known to be allergic to iodine. If irritation, redness or swelling develops, discontinue use of the product and institute appropriate measures. Blue stains on starched linen will wash off with soap and water.

Iodine absorption and subsequent excretion in breast milk may follow vaginal application of povidone-iodine.

Adverse Reactions: Although rare, local hypersensitivity reactions have occurred. Serum PBI may increase temporarily in some patients after topical application of povidone-iodine. tag_DosageDosage

Dosage And Administration: Aerosol Spray: Hold container about 25 cm from skin. Press valve firmly with index finger, spraying to cover desired area. Allow to dry. Replace cap after use. If actuator clogs, remove and soak in warm water. Treated area may be covered with gauze, adhesive bandage or plaster casts. Bottle operates in any position.

Gauze Pads: Apply as directed.

Mouth Wash/Gargle: As a routine mouth wash: use full strength or dilute to taste. Effective up to dilution of 1 part Betadine with 2 parts water. As a gargle or mouth wash: use full strength for 30 seconds, hourly, or as directed by physician or dentist.

Ointment: Apply directly to affected area as needed. May be bandaged.

Shampoo: Apply 10 mL to hair and scalp, using warm water to lather. Rinse and repeat, massaging gently into scalp. Allow lather to remain on scalp for at least 5 minutes. Work up lather, then rinse thoroughly. Repeat treatment twice weekly for 6 to 8 weeks, then weekly or as directed by physician.

Skin Cleanser: Wet the skin and apply a sufficient amount to cover the affected areas. Massage for 5 minutes, add a little water, continue to work up a lather, then rinse thoroughly. For oily skin and prevention of blemishes, wash face and neck or affected area several times weekly with Betadine Skin Cleanser and shampoo regularly with Betadine Shampoo.

Solution: Apply full strength as often as needed as a paint or wet soak. Allow to dry before applying surgical drapes and avoid "pooling" beneath the patient. Prolonged exposure to the solution may cause irritation or rarely, severe skin reaction. In rare instance of local irritation or sensitivity, discontinue use.

Surgical Scrub: A. Preoperative scrubbing by operating personnel: wet hands with water. Pour 5 mL on the palm of the hand and spread over both hands. Without adding more water, rub the scrub thoroughly over all areas for about 5 minutes. Use a soft brush if desired. Clean thoroughly under fingernails. Add a little water to develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 mL if desired.

B. Preoperative use on patients: wet the operative area with water. Apply scrub (1 mL is sufficient to cover an area of 125 to 200 cm and rub thoroughly for about 5 minutes. Then develop a lather and rinse off by aid of sterile gauze saturated with water. The area may then be painted with solution and allowed to dry.

C. Use in physician's office: Use for washing whenever a germicidal soap is required. For maximum degerming of the hands proceed as under (A). To prepare the patient's skin proceed as under (B).

Swab Aids: Prior to venipuncture and other injections, swab area to be cleansed. Allow to dry before inserting needle.

Availability And Storage: Aerosol Spray: Each mL of mahogany colored solution contains: povidone-iodine USP 5% (0.5% available iodine). Contains no chlorofluorocarbons. Pump spray bottles of 88 mL.

Gauze Pads: Each 7.6´22.8 cm fine mesh gauze pad contains: povidone-iodine USP 450 mg as a 10% solution in a viscous base. Packages of 10 and 50.

Mouth Wash/Gargle: Each mL of mahogany colored solution contains: povidone-iodine USP 1% (0.1% available iodine) and alcohol 8%. pH: 4 to 6. Bottles of 250 mL.

Ointment: Each g contains: povidone-iodine USP 10% (1% available iodine) in a water-soluble polyethylene glycol ointment base. pH (5% solution): 3.5 to 4.5. Packettes of 1 g, cartons of 144. Tubes of 20 g. Jars of 500 g.

Shampoo: Each mL contains: povidone-iodine USP 7.5% (0.75% available iodine). pH 4.5 to 5.5. Forms a rich golden, perfumed lather. Plastic squeeze bottles of 114 mL.

Skin Cleanser: Each mL of sudsing, antiseptic liquid cleanser contains: povidone-iodine USP 7.5% (0.75% available iodine) and detergents. pH 4.5 to 5.5. Plastic squeeze bottles of 114 and 250 mL.

Solution: Each mL of mahogany colored solution contains: povidone-iodine USP 10% (1% available iodine) with surfactant. pH 4.5 to 5.5. Plastic bottles of 25 mL, cartons of 40. Plastic bottles of 100 mL, 500 mL and 5 L.

Surgical Scrub: Each mL of mahogany colored liquid contains: povidone-iodine USP 7.5% (0.75% available iodine) with sudsing agent. pH 4.5 to 5.5. Plastic bottles of 100 mL, 500 mL and 5 L.

Swab Aids: Each germicide pad contains: 1 mL povidone-iodine 10% solution (1% available iodine). Cartons of 100.

Protect from excessive heat. Check label for expiration date.