NDC 42961-017 Signature Series Enriched Foam Alcohol Hand Sanitizer

Alcohol

NDC Product Code 42961-017

NDC CODE: 42961-017

Proprietary Name: Signature Series Enriched Foam Alcohol Hand Sanitizer What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 42961 - Cintas Corporation
    • 42961-017 - Signature Series Enriched Foam Alcohol Hand Sanitizer

NDC 42961-017-01

Package Description: 4 POUCH in 1 BOX > 500 mL in 1 POUCH

NDC Product Information

Signature Series Enriched Foam Alcohol Hand Sanitizer with NDC 42961-017 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Signature Series Enriched Foam Alcohol Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cintas Corporation

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Signature Series Enriched Foam Alcohol Hand Sanitizer 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.

  • ALCOHOL 75 mL/100mL

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)
  • CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • PEG/PPG-25/25 DIMETHICONE (UNII: ND6MYD0T84)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)

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.
  • 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: 05-08-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Signature Series Enriched Foam Alcohol Hand Sanitizer Product Label Images

Signature Series Enriched Foam Alcohol Hand Sanitizer 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

Other

Drug Facts

Active Ingredient

Alcohol Denat. 75% (v/v)

Purpose

Antiseptic cleanser

Use

To decrease potentially harmful germs on skin.

Warnings

  • Flammable. Keep away from fire or flame.For external use only.

Otc - When Using

  • When using this product avoid contact with eyes. In case of eye contact, flush with water.

Otc - Stop Use

  • Stop use and ask a doctor if irritation of redness develops or if condition persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.If swallowed, do not induce vomiting, get medical attention.Read material safety data sheet before using product

Directions

  • Apply generously to hands. Rub hands together. Allow hands to dry. Repeat daily as necessary.

Inactive Ingredients

Water (Aqua), PEG-6 Caprylic Glycerides, Sodium Lactate, PEG-14M, Silica, Disodium Lauriminodipropionate Tocopheryl Phosphates, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, PEG/PPG-25/25 Dimethicone, Shea Butteramidopropyl Betaine, Hexylene Glycol, Sodium Citrate, Lactic Acid

Questions?

1-800-347-9800 Mon.–Fri., 8 AM–5 PM EST.

* Please review the disclaimer below.