NDC 80950-3111 Antiseptic Wipe

Alcohol

NDC Product Code 80950-3111

NDC 80950-3111-1

Package Description: 100 PACKET in 1 BOX > 1 APPLICATOR in 1 PACKET > .0017 L in 1 APPLICATOR

NDC 80950-3111-3

Package Description: 160 APPLICATOR in 1 CANISTER > .00325 L in 1 APPLICATOR

NDC Product Information

Antiseptic Wipe with NDC 80950-3111 is a a human over the counter drug product labeled by Djo Llc. The generic name of Antiseptic Wipe is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Djo Llc

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Antiseptic Wipe 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 665 mL/100L
  • ALCOHOL 665 mL/100L

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.

  • ALOE (UNII: V5VD430YW9)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Djo Llc
Labeler Code: 80950
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: 12-14-2020 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.

Antiseptic Wipe 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 Ingredients

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

  • For handwashing to decrease bacteria on skin whenever soap and water is not readily available
  • Helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection

Warnings

For external use only. Flammable, keep away from fire or flame

Otc - Do Not Use

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop Use And Ask A Doctor If

  • Irritation or redness develop and persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away

Directions

  • Unsnap entire canister cap and thread towelette through pre-cut slot
  • Pull towelette out of cap slot at an angle to dispense
  • Wet hands and wrists thoroughly with wipe for 15 seconds and allow to air dry
  • Dispose of used towelette properly
  • Always reseal after use
  • Children under 6 years of age should be supervised when using this product

Inactive Ingredients

Aloe vera, fragrance, purified water, triethanolamine

* Please review the disclaimer below.