NDC 77031-105 Cubrete Antiseptic Hand Sanitizer

Ethyl Alcohol

NDC Product Code 77031-105

NDC 77031-105-01

Package Description: 4000 mL in 1 BOTTLE, PLASTIC

NDC 77031-105-02

Package Description: 50 mL in 1 BOTTLE, PLASTIC

NDC 77031-105-04

Package Description: 125 mL in 1 BOTTLE, PLASTIC

NDC 77031-105-08

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC 77031-105-16

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC 77031-105-33

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Cubrete Antiseptic Hand Sanitizer with NDC 77031-105 is a a human over the counter drug product labeled by Frozen Wheels, Llc. The generic name of Cubrete Antiseptic Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Frozen Wheels, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Cubrete Antiseptic Hand Sanitizer 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.

  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Frozen Wheels, Llc
Labeler Code: 77031
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: 07-08-2020 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.

Cubrete Antiseptic Hand Sanitizer Product Label Images

Cubrete Antiseptic Hand Sanitizer 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

Ethyl alcohol 70%v/v

Purpose

Antimicrobial

Uses

  • Hand Sanitizer to help reduce bacteria that potentially cause disease.For use when soap and water are not available.

Warnings

Flammable• Keep away from fire or flame. • For external use only.When using this product• Do not use it in or near the eyes. • In case of contact, rinse eyes thoroughly with water.Stop use and ask a doctor if skin irritation occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help in a Poison Control Center immediately.

Directions

  • Put enough product in your palm to cover hands and rub hands together briskly untill dry.Children under 6 years of age should be supervised when using this product.

Other Information

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

Questions?

+52 1 56 1876 7678    info@cubret.mx

Other

Alcohol BasedManufactured by: Corporativo Cubrete, S.A. de C.V. Calzada las Aguilas 1709, Interior B, Lomas de Guadalupe, Alvaro Obregon, C.P.01720 Made in MexioImported by: Frozen Wheels, LLC 16565 NW 15th Ave. Miami, FL 33169HECHO ENMEXICO

* Please review the disclaimer below.