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| Product NDC Code | 67326-352 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Antiseptic patient preoperative skin preparation and surgical hand scrub |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | SOLUTION | ||||||||||||
| RxCUI drug identifier | 211747 | ||||||||||||
| Application Number | 505G(a)(3) | ||||||||||||
| Labeler Name | Degasa SA De CV | ||||||||||||
| 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 7.5%
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 Patient preoperative skin preparation: Surgical hand scrub: Clean the area Apply product to the operative site prior to surgery Scrub thoroughly for 5 minutes Rinse off with a sterile gauze saturated with water Clean under nails with a nail pick. Nail should be maintained with a 1 millimeter free edge Wet hands and forearms Apply 5 millileters (teaspoonful) or palmfull to hands and forearms Scub thoroughly for 5 minutes with a sterile brush Paying particular attention to the nails, cuticles, and interdigital spaces Rinse and repeat scrub
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Disodium Phosphate, Glycerin, Hidroxyethylcellulose, Monoethanolamine, Dionized 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 Patient preoperative skin preparation: Surgical hand scrub: For preparation of the skin prior to surgery Helps reduce bacteria that potentially can cause skin infection Significantyl reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
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.Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub POVIDONE-IODINE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS GLYCERIN MONOETHANOLAMINE 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 1
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
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature 20-25°C (68-77°F)
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 Stop use and ask a doctor if In the eyes Heat prior to application On individuals who are allergic or sensitive to Iodine Irritation and redness develop If condition persists for more than 72 hous consult a doctor 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