Poviofix Antiseptic

Poviofix Antiseptic
SPL v4
SPL
SPL Set ID 7fddf55e-bd84-42d4-bb8f-ff84879d76f4
Route
TOPICAL
Published
Effective Date 2017-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Alcohol Glycerin Polysorbate 20 Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-09-25

Description

Povidone-iodine 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-iodine 10%

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.

Section 42229-5

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 [email protected] MADE IN TURKEY











Section 51945-4

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

Warnings

For external use only

Directions

Surgical hand scrub (for use without water):

Patient preoperative skin preparation:

First-aid antiseptic:

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

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

Drug Facts



Product Label

Active Ingredient

Povidone-iodine 10%

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

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.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or serious burns


Structured Label Content

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.

Section 42229-5 (42229-5)

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 [email protected] MADE IN TURKEY











Section 51945-4 (51945-4)

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

Purpose

Antiseptic

Warnings

For external use only

Directions

Surgical hand scrub (for use without water):

Patient preoperative skin preparation:

First-aid antiseptic:

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

Do Not Use (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

Drug Facts



Product Label

Active Ingredient (Active ingredient)

Povidone-iodine 10%

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

Inactive Ingredients (Inactive ingredients)

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

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites, or serious burns


Advanced Ingredient Data


Raw Label Data

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