NDC 63354-987 Wet Ones Hand Sanitizing Wipes Plus

Ethyl Alcohol

NDC Product Code 63354-987

NDC 63354-987-20

Package Description: 20 SWAB in 1 POUCH

NDC 63354-987-50

Package Description: 50 SWAB in 1 CANISTER

NDC Product Information

Wet Ones Hand Sanitizing Wipes Plus with NDC 63354-987 is a a human over the counter drug product labeled by Edgewell Personal Care Brands Llc. The generic name of Wet Ones Hand Sanitizing Wipes Plus is ethyl alcohol. The product's dosage form is swab and is administered via topical form.

Labeler Name: Edgewell Personal Care Brands Llc

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.

Wet Ones Hand Sanitizing Wipes Plus 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 .7 1/1

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Edgewell Personal Care Brands Llc
Labeler Code: 63354
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: 11-04-2020 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.

Wet Ones Hand Sanitizing Wipes Plus 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

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin

Warnings

For externak use only: handsFlammable. Keep away from heat and flame

Do Not Use

If you are allergic to any of the ingredients.

When Using This Product

- Keep out of eyes. In case of contact with eyes flush thoroughly with water.- Avoid contact with broken skin- Do not inhale or ingest

Stop Use And Ask A Doctor

If irritation or rash develops and continues for more than 72 hours

Keep Out Of Reach Of Children

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

Directions

Adults and children 2 years and over:- apply to hands.- allow skin to dry without wiping.children under 2 years: ask a doctor before use

Other Information

- do not store above 105℉ (41℃).- may discolor some fabrics- harmful to wood finishes and plastics

Inactive Ingredients

Water, Isopropyl Alcohol, Glycerin, Propanediol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

Primary Display Panel

With Aloe & Vitamin EWet Ones (tm)HAND SANITIZING WIPESPlus70% AlcoholKills 99.99% of Germs*Shopping Workplace Travel50 WipesShopping Workplace TravelWith Aloe & Vitamin EWet Ones (tm)HAND SANITIZING WIPESPlus70% AlcoholKills 99.99% of Germs*20Wipes

* Please review the disclaimer below.