NDC 77251-002 Sanidry Wipes

Disinfectant Cleaning Wipes

NDC Product Code 77251-002

NDC 77251-002-01

Package Description: 300 CLOTH in 1 PACKAGE

NDC 77251-002-02

Package Description: 1200 CLOTH in 1 PACKAGE

NDC Product Information

Sanidry Wipes with NDC 77251-002 is a a human over the counter drug product labeled by Quimica Rosmar S.a. De C.v.. The generic name of Sanidry Wipes is disinfectant cleaning wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Quimica Rosmar S.a. De C.v.

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.

Sanidry 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.

  • BENZALKONIUM CHLORIDE .133 1/1001

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)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • EDETATE SODIUM (UNII: MP1J8420LU)

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: Quimica Rosmar S.a. De C.v.
Labeler Code: 77251
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: 05-28-2020 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.

Sanidry Wipes Product Label Images

Sanidry 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

Benzalkonium chloride 0.13% (w/w)

Purpose

Antiseptic

Uses

  • For hand sanitizing to decrease bacteria on the skin when water and soap are not availableRecommended for repeated use.

Warnings

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

Otc - When Using

When using this product do not use in near eyes. If contact occurs, flush thoroughly with water.

Otc - Stop Use

Stop use and contact a doctor if irritation or redness persists for more than 72 hours.

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.

Directions

  • Remove wipeWet hand thoroughly with wipe and allow hands to dry without wiping.

Inactive Ingredients

Water, ethyl alcohol, glycerin, tetrasodium EDTA

Other Information

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

* Please review the disclaimer below.