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Product NDC Code | 76162-327 | ||||
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Drug Name | Topcare 3 hydrogen peroxide wipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
Application Number | M003 | ||||
Labeler Name | Topco Associates LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Hydrogen peroxide (stabilized) 3% Purpose First aid antiseptic
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 • apply product on the affected area of the body 1 to 3 times a day • 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 ingredient polysorbate 80, 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 first aid to help prevent the risk of infection in: • minor cuts • scrapes • burns
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.Topcare 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE POLYSORBATE 80 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 Labeling: Label5
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.Drug Facts
Other information • do not apply internally. • keep canister tightly closed and stored at room temperature. • hold away from face when opening
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 you have • deep or puncture wounds • animal bites • 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. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-423-0139
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 condition persists or gets worse.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • do not get in eyes • do not apply over large areas • do not use longer than 1 week unless directed by a doctor
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. Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns When using this product • do not get in eyes • do not apply over large areas • do not use longer than 1 week unless directed by a doctor Stop use and ask a doctor if condition persists or gets worse. 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