NDC 77133-002 O Well Sanitizing Hand Wipes


NDC Product Code 77133-002

NDC 77133-002-01

Package Description: 20 PATCH in 1 BAG > 4 mL in 1 PATCH

NDC 77133-002-02

Package Description: 50 PATCH in 1 BAG > 4 mL in 1 PATCH

NDC 77133-002-03

Package Description: 50 PACKET in 1 BOX > 1 PATCH in 1 PACKET > 3 mL in 1 PATCH

NDC Product Information

O Well Sanitizing Hand Wipes with NDC 77133-002 is a a human over the counter drug product labeled by Otc Outlet, Inc.. The generic name of O Well Sanitizing Hand Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Otc Outlet, Inc.

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.

O Well Sanitizing Hand 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.

  • ALCOHOL .75 mL/mL

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: Otc Outlet, Inc.
Labeler Code: 77133
FDA Application Number: part333E 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: 12-24-2020 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.

O Well Sanitizing Hand Wipes Product Label Images

O Well Sanitizing Hand 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

Active Ingredient

Alcohol 75%




  • Hand Sanitizer to help reduce bacteria on the skin


  • Open the flip and tear the seal stickerRemove the wipes from the middle hole and useClose the flip to prevent the wipes from drying out


For external use only.

Do Not Use

  • In or contact the eyes.

When Using This Product

  • These wipe do not replace wipe used for medical procedures. These wipes are meant for general cleansing.Keep in a dry place away from fire.Discontinue use if irritation and redness develop. If the condition persists for more than 72 hours, consult a physician.Please close the lid after dispending to maintain purity. Alcohol by nature evaporates quickly.Store below 95°F (35°C).

Keep This Out Of Reach Of Children.

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

Inactive Ingredients

Aqua, Glycerin, Benzalkonium

* Please review the disclaimer below.