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| Product NDC Code | 82996-006 | ||||
|---|---|---|---|---|---|
| Drug Name | Antiseptic povidone-lodine prep pad |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 797730 | ||||
| Application Number | M003 | ||||
| Labeler Name | Hubei Changjian Medical Products Co., Ltd. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Povidone-Iodine 10% w/w (1% available 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 for use: Clean the treatment area Apply to the treatment area or operative site before surgery
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients purified 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 antiseptic to help prevent the risk of infection in minor cut, scrapes, and burns.
Purpose
Information about the drug product’s indications for use.Purpose First aid antiseptic Pain relieving cream
Spl product data elements
Usually a list of ingredients in a drug product.Antiseptic Povidone-lodine Prep Pad POVIDONE-IODINE GLYCERYL MONOSTEARATE GLYCERIN 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.Package labeling: 82996-006-01 Antiseptic Povidone-Iodine Prep Pad 82996-006-01
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.Drug Facts
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 over large areas of the body as a first aid antiseptic for longer than one week unless directed by a physician on individuals who are sensitive or allergic to iodine if package is damaged or open
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
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, redness, or symptoms develops 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 Keep out of reach of children Single use only Keep out of reach of children Do not use: in the eyes over large areas of the body as a first aid antiseptic for longer than one week unless directed by a physician on individuals who are sensitive or allergic to iodine if package is damaged or open Stop use and ask a doctor if irritation, redness, or symptoms develops if the condition persists or gets worse.
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