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| Product NDC Code | 76162-809 | ||||
|---|---|---|---|---|---|
| Drug Name | Alcohol prep |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SWAB | ||||
| RxCUI drug identifier | 797544 | ||||
| Application Number | M003 | ||||
| Labeler Name | Topco Associates | ||||
| 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 Isopropyl Alcohol, 70% v/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 Apply to skin as needed Discard after single use
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.Uses First aid to decrease germs 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.Alcohol Prep Isopropyl Alcohol 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.Principal Display Panel Package 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 Distributed By: Topco Associates LLC. Elk Grove Village, IL 60007 ©TopCo MDLA0618 Questions? 1-888-423-0139 [email protected] www.topcarebrand.com Made in China RD20LPD
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 with electrocautery procedures longer than 1 week unless directed by 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. If accidentally swallowed, get medical help or contact a Poison Control Center right away.
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 gets worse or persists for more than 72 hours
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 into eyes do not apply over large areas of the body in case of deep or puncture wounds, animal bites or serious burns, consult a doctor
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect from freezing and avoid excessive heat.
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 with electrocautery procedures longer than 1 week unless directed by a doctor When using this product do not get into eyes do not apply over large areas of the body in case of deep or puncture wounds, animal bites or serious burns, consult a doctor Stop use and ask a doctor if irritation and redness develop condition gets worse or persists for more than 72 hours Keep out of reach of children. If accidentally 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