NDC 79705-002 Big Wipes Multi-purpose

Benzalkonium Chloride

NDC Product Code 79705-002

NDC 79705-002-01

Package Description: 4 mL in 1 POUCH

NDC 79705-002-03

Package Description: 110 mL in 1 CANISTER

NDC 79705-002-04

Package Description: 310 mL in 1 CANISTER

NDC 79705-002-06

Package Description: 1161 mL in 1 CANISTER

NDC Product Information

Big Wipes Multi-purpose with NDC 79705-002 is a a human over the counter drug product labeled by Sycamore Usa Inc.. The generic name of Big Wipes Multi-purpose is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Sycamore Usa 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.

Big Wipes Multi-purpose 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 1.3 mg/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.

  • METHYL SOYATE (UNII: 808DL597QP)
  • DIMETHYL GLUTARATE (UNII: 1I9VFA346P)
  • DIMETHYL METHYLGLUTARATE (UNII: 728OFW5M9G)
  • WATER (UNII: 059QF0KO0R)
  • DIMETHYL SUCCINATE (UNII: 914I2127JR)
  • DIMETHYL ADIPATE (UNII: BY71RX0R62)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALCOHOL (UNII: 3K9958V90M)

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: Sycamore Usa Inc.
Labeler Code: 79705
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: 08-31-2020 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’.

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Big Wipes Multi-purpose Product Label Images

Big Wipes Multi-purpose 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%

Purpose

Antibacterial

Uses

Ceans hands and reduces bacteria on the skin

Warnings

For external use only

Otc - When Using

When using this product do not use in or around eyes. May irritate eyes.
If IN EYES rinse well for 15 minutes

Directions

  • Open foil seal and pull the center wipe through the lidWipe handsFor best results, clean spills immediatelyAlways shut the lid after use and store at room temperature.

Inactive Ingredients

WATER (AQUA), DIMETHYL SUCCINATE, DIMETHYL GUTARATE, DIMETHYL ADIPATE, DIMETHYL METHYLGLUTARATE. POLYSORBATE-80, POLYSORBATE-20, DIDECYLDIMONIUM CHLORIDE, GLYCERIN, METHYL SOYATE, PEG-75 LANOLIN, ALCOHOL, CITRIC ACID, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE (VITAMIN E), PROPANEDIOL, PARFUM.

Questions?

Call (770) 628-0286 or visit www.bigwipesusa.com

* Please review the disclaimer below.