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| Product NDC Code | 81280-003 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Povidone-iodine |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SWAB | ||||||
| Application Number | M005 | ||||||
| Labeler Name | Mazza Healthcare, LLC | ||||||
| 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, USP, 10% v/v (equivalent to 1% titratable iodine)
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 clean the affected area for preparation of the skin prior to surgery, apply product to the operative site for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide Mazza Healthcare, LLC 1-877-629-9242
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 health care antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
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 Povidone-Iodine Iodine Citric Acid Monohydrate Glycerin Nonoxynol-10 Water Sodium Hydroxide
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 - 500 Pouch Carton Label MH Mazza Healthcare MODEL NO.: 02-053-00 DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE QUANTITY: 1 CASE (500 POUCHES X 3 EACH) LOT NO.: MANUFACTURE DATE: EXPIRY DATE: MANUFACTURED FOR: Mazza Healthcare, LLC Bannockburn, IL 60015 • USA MADE IN CHINA NDC 81280-003-03 Principal Display Panel - 500 Pouch Carton Label
Principal Display Panel - 3 Applicators Pouch Label MH Mazza Healthcare Povidone-Iodine Swabsticks NDC 81280-003-03 Antiseptic • Germicide • 4” Saturated Non-Sterile • Single Use Only 3/pouch Reorder Number 02-053-00 Principal Display Panel - 3 Applicators Pouch Label
Principal Display Panel - 500 Pouch Carton Label MH Mazza Healthcare MODEL NO.: 02-051-00 DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE QUANTITY: 1 CASE (500 POUCHES X 1 EACH) LOT NO.: MANUFACTURE DATE: EXPIRY DATE: MANUFACTURED FOR: Mazza Healthcare, LLC Bannockburn, IL 60015 • USA MADE IN CHINA NDC 81280-003-01 Principal Display Panel - 500 Pouch Carton Label
Principal Display Panel - 1 Applicator Pouch Label MH Mazza Healthcare Povidone-Iodine Swabstick NDC 81280-003-01 Antiseptic • Germicide • 4” Saturated Non-Sterile • Single Use Only 1/pouch Reorder Number 02-051-00 Principal Display Panel - 1 Applicator Pouch 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 or 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 on individuals who are allergic or sensitive to iodine over large areas of the body as first aid antiseptic longer than 1 week unless directed by doctor Discontinue use if irritation and redness develop.
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 59-86ºF (15-30ºC).
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 consult a doctor if the condition persists or gets worse.
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 on individuals who are allergic or sensitive to iodine over large areas of the body as first aid antiseptic longer than 1 week unless directed by doctor Discontinue use if irritation and redness develop. Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns. Stop use and consult a doctor if the condition persists or gets worse. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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