Prevantics Swab
Chlorhexidine Gluconate And Isopropyl Alcohol
Professional Disposables International, Inc.
Human Otc Drug
NDC 10819-1080Prevantics Swab also known as Chlorhexidine Gluconate And Isopropyl Alcohol is a human otc drug labeled by 'Professional Disposables International, Inc.'. National Drug Code (NDC) number for Prevantics Swab is 10819-1080. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Prevantics Swab drug includes Chlorhexidine Gluconate - 31.5 mg/mL Isopropyl Alcohol - .7 mL/mL . The currest status of Prevantics Swab drug is Active.
Drug Information:
| Drug NDC: | 10819-1080 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Prevantics Swab |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Chlorhexidine Gluconate And Isopropyl Alcohol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Professional Disposables International, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CHLORHEXIDINE GLUCONATE - 31.5 mg/mL
ISOPROPYL ALCOHOL - .7 mL/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 15 Jan, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA021524 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Professional Disposables International, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1191171
1366736
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | MOR84MUD8E
ND2M416302
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Decreased Cell Wall Integrity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 10819-1080-1 | 100 POUCH in 1 BOX (10819-1080-1) / 1 mL in 1 POUCH | 15 Jan, 2013 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antiseptic antiseptic
Product Elements:
Prevantics swab chlorhexidine gluconate and isopropyl alcohol chlorhexidine gluconate chlorhexidine water isopropyl alcohol isopropyl alcohol
Indications and Usage:
Use for the preparation of the patient's skin prior to an injection
Warnings:
Warnings for external use only flammable, keep away from fire or flame do not use with electrocautery procedures allergy alert this product may cause a severe allergic reaction. symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash if an allergic reaction occurs, stop use and seek medical help right away do not use on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser under occlusive patch when using this product keep out of eyes, ears, mouth and mucous membranes. may cause serious or permanent injury if permitted to enter and remain. if contact occurs, rinse with cold water right away and contact a doctor. _________________________________________________________________ stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. these may be signs of a serious condition. keep out of reach of chi
Read more...ldren. if swallowed, get medical help or contact a poison control center right away.
Allergy alert this product may cause a severe allergic reaction. symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash if an allergic reaction occurs, stop use and seek medical help right away
Do Not Use:
Warnings for external use only flammable, keep away from fire or flame do not use with electrocautery procedures allergy alert this product may cause a severe allergic reaction. symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash if an allergic reaction occurs, stop use and seek medical help right away do not use on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser under occlusive patch when using this product keep out of eyes, ears, mouth and mucous membranes. may cause serious or permanent injury if permitted to enter and remain. if contact occurs, rinse with cold water right away and contact a doctor. _________________________________________________________________ stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. these may be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Allergy alert this product may cause a severe allergic reaction. symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash if an allergic reaction occurs, stop use and seek medical help right away
When Using:
When using this product keep out of eyes, ears, mouth and mucous membranes. may cause serious or permanent injury if permitted to enter and remain. if contact occurs, rinse with cold water right away and contact a doctor. _________________________________________________________________
Dosage and Administration:
Directions use with care in premature infants or infants under 2 months of age. these products may cause irritation or chemical burns. maximum treatment area for one swab is approximately 2.5 by 2.5 inches (6 by 6 cm) tear open packet and remove swab. do not unfold swab. prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. apply swab to skin using repeated back-and-forth strokes for 15 seconds. allow the prepped area to air dry for 30 seconds do not blot or wipe dry discard after a single use
Package Label Principal Display Panel:
Package/label principal display panel reorder no. b10800 ndc 10819-1080-1 prevantics (r) swab [chlorhexidine gluconate (3.15%) and isopropyl alcohol (70%) swab] antiseptic non-sterile solution for external use only single step, broad spectrum, persistent antiseptic that significantly reduces the number of microorganisms on intact skin use for the preparation of the patient's skin prior to an injection helps reduce bacteria that potentially can cause skin infection latex free for hospital and professional use only important: see carton for complete drug facts and safety information. packet label box label packet box