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| Product NDC Code | 69740-212 | ||||
|---|---|---|---|---|---|
| Drug Name | I.v. prep antiseptic wipe |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 797544 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Smith & Nephew, Medical Ltd | ||||
| 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 INGREDIENTS (IN EACH PACKET) Isopropyl Alcohol 70% v/v
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATION Should not be used on full-term or premature babies less than 1 month
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 area start at the venipuncture site and apply in a circular fashion using friction Let dry and repeat procedure Allow I.V. PREP to dry prior to application of dressings
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS acetyl tributyl citrate, butyl ester of PVM/MA copolymer, benzalkonium chloride, 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 For preparation of skin prior to injection or venipuncture
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.I.V. Prep Antiseptic Wipe ISOPROPYL ALCOHOL ACETYLTRIBUTYL CITRATE WATER BENZALKONIUM CHLORIDE 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.PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - BOX OF 50 WIPES (Front) #59421200 NDC 69740-212-00 I.V. PREP (isopropyl alcohol, 70%) Antiseptic Wipes Sterile Solution For preparation of the skin prior to injection or venipuncture 50 Wipes PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 1 Packet #59421200 NDC 69740-212-00 I.V. PREP (isopropyl alcohol, 70%) Antiseptic Wipe Sterile Solution For preparation of the skin prior to injection or venipuncture 1 Wipe Made in the USA for Smith & Nephew Medical Ltd 101 Hessle Road, Hull, HU3 2BN, England Customer Care Center: 1 800 876-1261 www.smith-nephew.com 50 wipes 1 Wipe
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
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 Poisin Control Center immediately
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Made in the USA for Smith & Nephew Medical Ltd 101 Hessle Road, Hull, HU3 2BN, England Customer Care Center: 1 800 876-1261 www.smith-nephew.com
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 FLAMMABLE Use in a well-ventilated area and avoid using near flames or sources of ignition i.e. electrocautery procedures Sterile . Do not use if pack is open or damaged For external use only. Do not use in or near the eyes Discontinue use if irritation or redness develop. If condition persists more than 72 hours, consult a physician Limit exposure only to the immediate application site. Avoid use on children less than 12 years old as it may lead to irritation
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