NDC 77878-026 Wipe Out 3 Pack 2 Lemon Scent 1 Fresh Scent

Benzalkonium Chloride

  1. Labeler Index
  2. Tzumi Innovations Llc
  3. NDC: 77878-026 Wipe Out 3 Pack 2 Lemon Scent 1 Fresh Scent

NDC Product Code 77878-026

NDC CODE: 77878-026

Proprietary Name: Wipe Out 3 Pack 2 Lemon Scent 1 Fresh Scent What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Benzalkonium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 77878 - Tzumi Innovations Llc
    • 77878-026 - Wipe Out 3 Pack 2 Lemon Scent 1 Fresh Scent

NDC 77878-026-01

Package Description: 1 KIT in 1 KIT * 2 CANISTER in 1 PACKAGE (77878-024-01) > 80 SOLUTION in 1 CANISTER * 80 SOLUTION in 1 CANISTER (77878-025-01)

NDC Product Information

Wipe Out 3 Pack 2 Lemon Scent 1 Fresh Scent with NDC 77878-026 is a a human over the counter drug product labeled by Tzumi Innovations Llc. The generic name of Wipe Out 3 Pack 2 Lemon Scent 1 Fresh Scent is benzalkonium chloride. The product's dosage form is kit and is administered via form.

Labeler Name: Tzumi Innovations Llc

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Tzumi Innovations Llc
Labeler Code: 77878
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: 12-20-2020 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.

Wipe Out 3 Pack 2 Lemon Scent 1 Fresh Scent Product Label Images

Wipe Out 3 Pack 2 Lemon Scent 1 Fresh Scent 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

Wipe Out Antibacterial Wipes Lemon Scent

WIPE OUT ANTIBACTERIAL WIPES Lemon Scent

Active Ingredient

Benzalkonium Chloride 0.13%

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Antibacterial

Use

■ To decrease bacteria on the skin that could cause disease

Warnings

For external use onlyWhen using this product, keep out of eyes


In case of contact with eyes, flush thoroughly with water


Avoid contact with broken skin

For external use onlyWhen using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.Avoid contact with broken skin

Stop Use

Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours

Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Wet hands thoroughly with product and allow to dry without wipingFor children under 6, use only under adult supervisionNot recommended for infants

Wet hands thoroughly with product and allow to dry without wipingFor children under 6, use only under adult supervisionNot recommended for infants

Other Information

Keep containers tightly closed in a dry, cool and well ventilated place


Recommended storage temperature: 32F to 104F (0C to 40C)

Keep containers tightly closed in a dry, cool and well ventilated place


Recommended storage temperature: 32F to 104F (0C to 40C)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Fragrance, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water

Aloe Barbadensis Leaf Juice, Fragrance, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water

Wipe Out Antibacterial Wipes Fresh Scent

WIPE OUT ANTIBACTERIAL WIPES Fresh Scent

Uses

To decreases bacteria on the skin that could cause disease

* Please review the disclaimer below.