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| Product NDC Code | 58228-2610 | ||||
|---|---|---|---|---|---|
| Drug Name | Alcohol wipes |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SWAB | ||||
| RxCUI drug identifier | 797544 | ||||
| Application Number | M003 | ||||
| Labeler Name | Front Line Safety | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Isopropyl Alcohol 70%
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 • When used for first aid: Clean the affected area. 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. When used to prepare an injection site: Apply product to the injection site prior to injection.
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(s) • First aid to help prevent infection in minor cuts, scrapes, and burns. • For preparation of the skin prior to an injection.
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.Alcohol Wipes Alcohol Wipes WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL
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.FL-2010 FL-2010_BX_MASTER
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, or serious burns.
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 • In the eyes or over large areas of the body • Longer than 1 week unless directed by a doctor • With electrocautery procedures
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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • Store at room temperature 15º-30°C (59°-86ºF) • Avoid excessive heat
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-900-2920 Monday-Friday, 8AM-4PM PST
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 for more than 72 hours or gets worse
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 Flammable. Keep away from fire or flame. Do not use • In the eyes or over large areas of the body • Longer than 1 week unless directed by a doctor • With electrocautery procedures Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns. Stop use and ask a doctor if condition persists for more than 72 hours or gets worse Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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