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| Product NDC Code | 55681-752 | ||||
|---|---|---|---|---|---|
| Drug Name | Povidone iodine |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SWAB | ||||
| RxCUI drug identifier | 797730 | ||||
| Application Number | part333A | ||||
| Labeler Name | TwinMed 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, 10% (equivalent 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: Tear at notch Remove applicator Discard applicator after single use. As a first aid antispetic 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 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: Citric Acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate UPS, Sodium Phosphate Dibasic, 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: First aid to help prevent infection in minor cuts, scrapes and burns Patient preoperative skin preparation.Helps to reduce bacteria that potentially can 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 POLYSORBATE 80 CITRIC ACID MONOHYDRATE WATER POVIDONE-IODINE IODINE SODIUM PHOSPHATE DIBASIC DIHYDRATE GLYCERIN SODIUM CITRATE
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 PROCURE HEALTHCARE PRODUCTS Single Pack POVIDONE IODINE SWABSTICKS Antiseptic 50 Swabsticks Per Box 10 Boxes Per Case 500 Swabsticks Total 1 3 2
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 Longer than one week unless directed by a doctor On individuals who are allergic or sensitive to iodine Or apply 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.
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: Irritation and redness develops If condition persists for more than 72 hours, consult a physician.
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