NDC 79089-501 Freshquitas Antiseptic Hand Wipes

Alcohol

NDC Product Code 79089-501

NDC 79089-501-01

Package Description: 10 PACKAGE in 1 PACKAGE > 32 mL in 1 PACKAGE

NDC 79089-501-02

Package Description: 40 PACKAGE in 1 PACKAGE > 110 mL in 1 PACKAGE

NDC 79089-501-03

Package Description: 150 CANISTER in 1 PACKAGE > 411 mL in 1 CANISTER

NDC Product Information

Freshquitas Antiseptic Hand Wipes with NDC 79089-501 is a a human over the counter drug product labeled by Carmel Industria E Comercio De Produtos De Higiene E Limpeza Ltda. The generic name of Freshquitas Antiseptic Hand Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Carmel Industria E Comercio De Produtos De Higiene E Limpeza Ltda

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.

Freshquitas Antiseptic 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 70 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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
  • ALMOND OIL (UNII: 66YXD4DKO9)

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: Carmel Industria E Comercio De Produtos De Higiene E Limpeza Ltda
Labeler Code: 79089
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: 03-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Freshquitas Antiseptic 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

Other

  • This is a package of hand sanitizer wipes containing the following ingredients:Alcohol (ethanol) (70% volume/volume (v/v)).AquaPropylene Glycol,Phenoxyethanol, PEG-40Hydrogenated Castor OilPEG-12 DimethiconePrunus Amygdalus Dulcis (Sweet Almond) OilEdetate DisodiumThe firm does not add other active or inactive ingredients.

Active Ingredient(S)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic Hand Wipes

Use

  • For hand washing to decrease bacteria on the skin diseaseRecommended for repeated use

Warnings

For external use only.Flammable. Keep away from fire or flame.Allergy Alert: Contains Almond Oil.

Otc - When Using

  • When using this product:avoid contact with eyes, ears, and mouth. If contact occurs with eyes, flush thoroughly with wateravoid contact with broken skinavoid inhalationif inhaled for prolonged period, seek immediate medical attention

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Do Not Use

  • In children less than 2 months of ageif you are allergic to any ingredientson open skin wounds

Directions

  • Remove wet wipe and apply thoroughly to hands as desiredAllow to dry without wipingSupervise children in the use of this productUse only as directed.

Other Information

  • Store between 59-86°FKeep sealed after between usesAvoid freezing and heat above 104°FMay discolor certain fabrics or surfaces

Inactive Ingredients

Aqua, Propylene Glycol, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, PEG-12 Dimethicone, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Edetate Disodium

* Please review the disclaimer below.