NDC 68599-5808 Instant Hand Sanitizing Wipe

Ethyl Alcohol

NDC Product Code 68599-5808

NDC 68599-5808-6

Package Description: 160 SWAB in 1 BOX

NDC Product Information

Instant Hand Sanitizing Wipe with NDC 68599-5808 is a a human over the counter drug product labeled by Mckesson. The generic name of Instant Hand Sanitizing Wipe is ethyl alcohol. The product's dosage form is swab and is administered via topical form.

Labeler Name: Mckesson

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Instant Hand Sanitizing 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 65.9 mg/1

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.

  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • ALOE (UNII: V5VD430YW9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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.
  • 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: Mckesson
Labeler Code: 68599
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: 02-24-2020 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.

Instant Hand Sanitizing Wipe Product Label Images

Instant Hand Sanitizing 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

Otc - Active Ingredient

Active ingredient
Ethyl Alcohol 65.9% by volume

Otc - Purpose

Purpose
Antiseptic

Indications & Usage

  • UsesFor handwashing to decrease bacteria on the skin.For sanitizing hands after assisting ill persons, or Prior to contacting with a person under medical care or treatmentTopical Application to skin to help prevent cross-contamination.

Warnings

Warnings
Flammable. Keep away from fire, flame or source of ignition i.e. electrocautery procedures.

For external use only.

Otc - Stop Use

Do not use in or contact with eyes.

Discontinue use if irritation and redness develop. If condition persists more than 72 hours, consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children unless under adult supervision.

if swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions
To dispense, remove cover, discard seal from container, pull center sheet from roll, twist wipe to a point and thread through dispenser hole in cover.

Replace cover. Pull out wipe and snap off at 90 degree angle. The next wipe is ready for dispensing. Apply wipe thoroughly onto hands and allow to dry.

No rinsing required. Discard after single use. Dispose of used wipes in trash receptacle. Do not flush. When not in use, keep lid closed to prevent evaporation.

Other Safety Information

Other information
Lot No. and Expiration Date can be found on canister.

Store at 53.6 - 93.2*F (12-34*C)

Inactive Ingredient

Inactive ingredients
Aminomethyl Propanol, Aloe, Barbadensis Leaft Powder, Carbomer, Glycerin, Propylene Glycol, Tocopheryl Acetate, Water

Otc - Questions

Questions? Call 1-800-777-4908

* Please review the disclaimer below.