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| Product NDC Code | 52380-0012 | ||||
|---|---|---|---|---|---|
| Drug Name | Aplicare |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 312564 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Aplicare Products, 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 USP 10% w/v
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 antiseptic skin preparation: apply locally as needed.
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.Uses for preparation of the skin prior to surgery helps 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.Aplicare Povidone-Iodine POVIDONE-IODINE IODINE C12-20 ALKYL GLUCOSIDE SODIUM HYDROXIDE NONOXYNOL-10 HYDROXYETHYL CELLULOSE, UNSPECIFIED GLYCERIN CITRIC ACID POTASSIUM IODIDE WATER
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 Label label
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.Manufacturing information www.medline.com ©2024 Medline Industries, LP Aplicare is a registered trademark of Medline Industries, LP Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA 1-800-MEDLINE Made in China. V1 RL24CZU
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 if allergic to iodine in the eyes or apply over large areas of the body in case of deep or puncture wounds, animals bites, or serious burns, consult a doctor
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. In case of accidental ingestion, seek professional assistance or consult 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.Avoid pooling beneath patient
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.Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor
Storage and handling
Information about safe storage and handling of the drug product.Other information 1% titratable iodine not made with natural rubber latex for hospital or professional use only protect from freezing, avoid excessive heat store at room temperature
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 if allergic to iodine in the eyes or apply over large areas of the body in case of deep or puncture wounds, animals bites, or serious burns, consult a doctor Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor Avoid pooling beneath patient Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
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