NDC 77081-002 400 Wet Wipes

Isopropyl Alcohol

NDC Product Code 77081-002

NDC 77081-002-40

Package Description: 400 PACKAGE in 1 CANISTER > 4.2 mL in 1 PACKAGE

NDC Product Information

400 Wet Wipes with NDC 77081-002 is a a human over the counter drug product labeled by D D Office Products, Inc.. The generic name of 400 Wet Wipes is isopropyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: D D Office Products, 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.

400 Wet 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.

  • ISOPROPYL 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.

  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • BETAINE (UNII: 3SCV180C9W)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • 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: D D Office Products, Inc.
Labeler Code: 77081
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: 07-15-2020 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.

400 Wet Wipes Product Label Images

400 Wet 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 Ingredients

ISOPROPYL ALCOHOL 75%

Purpose

Antiseptic

Use

Hand sanitizer to decrease bacteria on the skin.

Warnings

For external use onlyKeep out of reach of eyes. If contact occurs, rinse thoroughly with water.Do not use if you are allergic to any of the ingredients.Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children unless under adult supervision.If swallowed, get medical help.

Direction

Wet hands thoroughly with product and allow to dry without wiping.

Additional Information:

• Store below 110 °F (43°C)• May discolor certain fabrics or surfaces

Inactive Ingredients

HexadecylPyridinium chloride, Propanediol, Dodecyl polyglucoside Vitamin E, Amino acid moisturizer, Citric acid, Glycerol, Sodium citrate, Aloe Vera Extract, Water

* Please review the disclaimer below.