POVIOFIX ANTISEPTIC- povidone-iodine solution

POVIOFIX Antiseptic by

Drug Labeling and Warnings

POVIOFIX Antiseptic by is a Otc medication manufactured, distributed, or labeled by NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone-iodine 10%

Purpose

Antiseptic

Uses

• Surgical hand scrub: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
• Patient preoperative skin preparation: for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
• First aid to help decrease the risk of infection in minor cuts, scrapes, and burns.
  

Warnings

For external use only

Do not use

- in the eyes   - over large areas of the body    - longer than 1 week unless directed by a doctor    - if you are allergic to iodine

Ask a doctor before use if you have

deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Surgical hand scrub (for use without water):

• clean under nails with a nail pick
• nails should be maintained with a 1 millimeter free edge
• place a ‘palmful’ (5 grams) of product in one hand spread on both hands, paying particular attention to the nails, cuticles, and interdigital spaces, and rub into the skin until dry (approximately 1 to 2 minutes)
• place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist, and rub into the skin until dry (approximately 30 seconds)

Patient preoperative skin preparation:

• clean the area
• apply product to the operative site prior to surgery

First-aid antiseptic:

• clean the affected area. May be covered with a sterile bandage.
• If bandaged, let dry first.
• If used as a wet compress bandage lightly. Keep bandage wet with solution.
  

Other information

• keep the product under 77°F (25°F) and away from food and children
• keep product sealed after opening
  

Inactive ingredients

denatured ethyl alcohol, glycerin, polysorbate 20, potassium iodine, trisodium citrate

SPL UNCLASSIFIED SECTION

TO REPORT A SERIOUS ADVERSE EVENT CONTACT [?]
YAKUPLU DISTRICT, BEYSAN INDUSTRIAL SITE,
BIRLIK STR, NAKIPOGLU CENTRE NO 12. FLOOR 1.
BEYLIKDUZU/ISTANBUL/TURKEY
TEL: (0212)476 28 68 /476 58 88 FAX: (0212)476 08 98
INFO@NATURELMEDIKAL.COM.TR
MADE IN TURKEY

PRINCIPAL DISPLAY PANEL

NATUREL   For People POVIOFIX Antiseptic Solution  Povidone-iodine 10%  33.8 fl oz (1.05 qt) (1 l)

Product Label

INGREDIENTS AND APPEARANCE

POVIOFIX ANTISEPTIC 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69249-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69249-000-00	1 in 1 CARTON	09/25/2014
1		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/25/2014

Labeler - NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI (355602127)