POVIOFIX Antiseptic

Manufacturer
NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:05:10

Label at a glance#

ProductPOVIOFIX Antiseptic
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and 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.

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

- 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

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PovioFixPovioFix

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN4
312564povidone-iodine 100 MG/ML Topical SolutionSCD4
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69249-000-002025-01-30C16284748780-12cef2736-7c16-d83d-e063-dadaa90ab31fPOVIOFIX Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69249-000-00POVIOFIX Antiseptic1000 mL in 1 BOTTLESOLUTION10004
69249-000-00POVIOFIX Antiseptic1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69249-000POVIOFIX ANTISEPTIC (POVIDONE-IODINE) SOLUTION [NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI]4Legacy NDC, 2 package rows20231221_7fddf55e-bd84-42d4-bb8f-ff84879d76f4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
IODINEACTIVE MOIETY9679TC07X41
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69249-00069249-000-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 162 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHEMULSION / TOPICAL2 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCAPSULE / ORAL563 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d000ab5-873c-ef8c-e063-6394a90a77fd7fddf55e-bd84-42d4-bb8f-ff84879d76f42023-12-21WarningsExact identifier
spl id: 0d000ab5-873c-ef8c-e063-6394a90a77fd
spl set id: 7fddf55e-bd84-42d4-bb8f-ff84879d76f4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.