NDC 42961-019 Xpect Alcohol Wipes

Alcohol Wipes

NDC Product Code 42961-019

NDC 42961-019-02

Package Description: 50 PACKET in 1 BOX > .7 mL in 1 PACKET (42961-019-01)

NDC Product Information

Xpect Alcohol Wipes with NDC 42961-019 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Xpect Alcohol Wipes is alcohol wipes. The product's dosage form is sponge and is administered via topical form.

Labeler Name: Cintas Corporation

Dosage Form: Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Xpect Alcohol Wipes Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ISOPROPYL ALCOHOL .7 1/.7mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cintas Corporation
Labeler Code: 42961
FDA Application Number: part333A What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-10-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Xpect Alcohol Wipes Product Label Images

Xpect Alcohol Wipes Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Warnings

  • For External Use OnlyFlammable, keep away from fire or flameDo not use in eyes or apply over large areas of the bodylonger than 1 week unless directed by a doctorAsk a doctor before use if you havedeep or puncture woundsanimal bitesserious burnsStop use and ask a doctor ifcondition persists or gets worseKeep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away

Directions

Clean the affected areaApply a small amount 1 to 3 times dailyMay be covered with a sterile bandage, if bandaged, let dry first

Uses

First aid to help prevent infection in minor cuts, scrapes, and burns

First aid to help prevent infection in minor cuts, scrapes, and burns.

Other Information

Do not use if packet is torn, cut, or openedStore at room temperature 15-30C (59-86F).

Questions?

1-877-973-2811 Monday-Friday 8:00am-5:00pm

Active Ingredients

Isopropyl alcohol 70%.....................first aid antiseptic

* Please review the disclaimer below.