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| Product NDC Code | 80514-002 | ||||
|---|---|---|---|---|---|
| Drug Name | 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 | 505G(a)(3) | ||||
| Labeler Name | JIANGSU HAIDA INTERNATIONAL TRADING CO., LTD. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Povidone Iodine USP, 10% w/w
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 Open packet and use as a washcloth.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT Ctric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, 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.Use Antiseptic for preparation of the skin.
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 pad povidone-iodine GLYCERIN POTASSIUM IODIDE HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) WATER CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE POVIDONE-IODINE IODINE NONOXYNOL-10 C12-20 ALKYL GLUCOSIDE
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.DRUG FACTS label-1 povidone-Iodine prep pad
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.CAUTION: Keep out of reach of children If swallowed, get medical help or contact Poison Control Center right away.
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. Discontinue use if irritation and redness develop.
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