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Povidone iodine - Medication Information

Product NDC Code 68786-130
Drug Name

Povidone iodine

Type Brand
Active Ingredients
Povidone-iodine .1 g/1
Route TOPICAL
Dosage Form SWAB
RxCUI drug identifier 797730
Application Number M003
Labeler Name Sion Biotext Medical Ltd
Packages
Package NDC Code Description
68786-130-01 50 packet in 1 box (68786-130-01) / 1 swab in 1 packet
68786-130-02 25 packet in 1 box (68786-130-02) / 3 swab in 1 packet
68786-130-03 50 packet in 1 box (68786-130-03) / 1 swab in 1 packet
68786-130-04 50 packet in 1 box (68786-130-04) / 1 swab in 1 packet
68786-130-05 25 packet in 1 box (68786-130-05) / 3 swab in 1 packet
68786-130-06 50 packet in 1 box (68786-130-06) / 1 swab in 1 packet
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Povidone Iodine 10%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Tear at notch Remove applicator Use only once As a first aid antispetic Clean affected area apply 1-3 times daily May be covered with a sterile bandage If bandaged, let dry first. For preoperative patient skin preparation Clean area Apply to operative site prior to surgery using applicator

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Nonoxynol-9, water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Antiseptic cleanser to help prevent infection in minor cuts, scrapes and burns. For preparation of the skin prior to surgery. Helps reduce bacteria that can potentially cause skin infection.

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
Povidone Iodine POVIDONE-IODINE NONOXYNOL-9 WATER POVIDONE-IODINE IODINE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel NDC 68786-130-01 50 Packets Povidone-Iodine Swabsticks Antispetic/Germicide For External Use Only Sion Biotext Medical Ltd. Label

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have Deep or puncture wounds Animal bites Serious burns

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use In the eyes As a first aid antiseptic for more than 1 week Over large areas of the body

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information Store at room temperature Avoid excessive heat

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if Condition worsens or persists for more than 72 hours Irritation and redness develops

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For External Use Only.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API