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| Product NDC Code | 52380-0013 | ||||
|---|---|---|---|---|---|
| Drug Name | Aplicare hydrogen peroxide |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 91349 | ||||
| Application Number | M003 | ||||
| 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 Hydrogen peroxide USP 3%
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 • apply locally as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 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 topical anti-infective
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Aplicare Hydrogen Peroxide Hydrogen Peroxide WATER HYDROGEN PEROXIDE HYDROGEN PEROXIDE
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 front back
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Recent Major Changes Indications and Usage Warnings and Precautions Dosage and Administration
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 Manufactured by: Aplicare Products, LLC. 550 Research Parkway, Meriden, CT 06450 USA 1-800-633-5463 0110
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if injuries are • deep or 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. 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 • not made with natural rubber latex • 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 • infection occurs • redness, irritation, swelling or pain persists or increases
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. Avoid pooling beneath patient Ask a doctor before use if injuries are • deep or puncture wounds • serious burns Stop use and ask a doctor if • infection occurs • redness, irritation, swelling or pain persists or increases 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