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| Product NDC Code | 0404-0121 | ||||
|---|---|---|---|---|---|
| Drug Name | Henry schein povidone-iodine prep pad |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SWAB | ||||
| RxCUI drug identifier | 797730 | ||||
| Application Number | M003 | ||||
| Labeler Name | Henry Schein, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Povidone Iodine USP 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 Clean area. Apply to the operative site prior to surgery
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide
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.Use For preparation of the skin prior to surgery
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.Henry Schein Povidone-Iodine Prep Pad POVIDONE-IODINE GLYCERIN HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) NONOXYNOL-10 ANHYDROUS CITRIC ACID SODIUM HYDROXIDE WATER POTASSIUM IODIDE 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 - 0.5 mL Item Label NDC 0404-0121-01 HENRY SCHEIN ® REF 570-1543 POVIDONE-IODINE PREP PAD 10% Povidone-Iodine For Professional and Hospital Use Not Made with Natural Rubber Latex HENRY SCHEIN SEAL OF EXCELLENCE ® 1/Pouch Principal Display Panel - 0.5 mL Item Label
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. Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
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 or gets in eyes, 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 1 % titratable iodine. Store at ambient temperatures
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 apply to persons allergic to iodine. Do not use in the eyes. Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns. Keep out of reach of children If swallowed or gets in eyes, 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