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| Product NDC Code | 52380-0946 | ||||
|---|---|---|---|---|---|
| Drug Name | Aplicare |
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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 | Aplicare Products LLC | ||||
| 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 clean the affected area for first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, disodium phosphate, 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 antiseptic skin preparation first aid to help prevent infection in minor cuts, scrapes, and burns
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 CITRIC ACID MONOHYDRATE POVIDONE-IODINE IODINE WATER SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
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.Manufacturer 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. Made in China. 1-800-MEDLINE. V1 RI24LPD
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.Other information 1% titratable iodine not made with natural rubber latex for hospital or professional use only for single use only protect from freezing, avoid excessive heat
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 and redness develop condition persists for more than 72 hours or gets worse in case of deep or puncture wounds, animal bites, or serious burns Avoid pooling beneath patient
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 Do not use if allergic to iodine in the eyes or apply over large areas of the body longer than 1 week unless directed by a doctor For external use only Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours or gets worse in case of deep or puncture wounds, animal bites, or serious burns 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