NDC 77087-001 Cabeau Sanitizer To Go

Alcohol

NDC Product Code 77087-001

NDC 77087-001-01

Package Description: 30 mL in 1 BOTTLE

NDC 77087-001-02

Package Description: 60 mL in 1 BOTTLE

NDC Product Information

Cabeau Sanitizer To Go with NDC 77087-001 is a a human over the counter drug product labeled by Cabeau Inc.. The generic name of Cabeau Sanitizer To Go is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cabeau Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Cabeau Sanitizer To Go 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 .7 mL/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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Cabeau Inc.
Labeler Code: 77087
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: 06-01-2020 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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Cabeau Sanitizer To Go Product Label Images

Cabeau Sanitizer To Go 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%

Purpose

Antiseptic

Uses

  • To reduce bacteria on the skin that could cause diseaseuse when soap and water are not available

Warnings

For external use only: handsFlammable. Keep away from heat and flame.

Do Not Use

  • On children less than 2 months of age on open skin wounds

When Using This Product

  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not inhale or ingest

Stop Use And Ask A Doctor If

  • Irritation or redness develop condition persists for more than 72 hours

Keep Out Of Reach Of Children.

If swallowed, get medical help or call a Poison Control Center right away.

Directions

  • Wet hands thoroughly with product and rub hands unitl dryfor children under 6, use only under adult supervision to avoid swallowing not for infants

Other Information

  • Do not store above 105°Fmay discolor some fabrics

Inactive Ingredients

Water, glycerin, propylene glycol, carbomer, sodium hydroxide, fragrace

Questions?

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* Please review the disclaimer below.