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| Product NDC Code | 68786-132 | ||||
|---|---|---|---|---|---|
| Drug Name | Povidone iodine prep |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 312564 | ||||
| Application Number | M003 | ||||
| Labeler Name | Sion Biotext Medical Ltd | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Povidone Iodine 10% w/v
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 Use only once As a first aid antiseptic Clean affected area apply 1 to 3 times daily May be covered with a sterile bandage If bandaged, let dry first. For preoperative patient skin preparation Clean affected 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 skin 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 Prep 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 PVP Prep Solution First Aid Antiseptic NET WT. 0.75 oz 500 Packets per Case Made in Israel NDC 68786-132-01 untitled.jpg
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information Store at room temperature Avoid excessive heat
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 wounds
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 immediately.
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. Do not use In the eyes As a first aid antiseptic for more than 1 week Over large areas of the body Ask a doctor before use if you have Deep or puncture wounds Animal bites Serious wounds Stop use and ask a doctor if Condition worsens or persists for more than 72 hours Irritation and redness develops Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.
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