NDC 77328-002 Alcohol Hand Sanitizer

Alcohol

NDC Product Code 77328-002

NDC 77328-002-01

Package Description: 250 mL in 1 BOTTLE, PUMP

NDC Product Information

Alcohol Hand Sanitizer with NDC 77328-002 is a a human over the counter drug product labeled by Clean Sleek Corporation. The generic name of Alcohol Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Clean Sleek Corporation

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.

Alcohol 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.

  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Clean Sleek Corporation
Labeler Code: 77328
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: 05-07-2020 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.

Alcohol Hand Sanitizer Product Label Images

Alcohol 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

Otc - Active Ingredient

Alcohol 75% v/v. Purpose: Antiseptic

Otc - Purpose

Antiseptic, Hand Sanitizer

Uses

  • To decrease bacteria on the skin that could cause diseaserecoomended for repeated use

Warning

For external use only: handsFlammable, keep away from fire or flame

When Using This Product

  • Keep out of eyes. In cases of contact with eyes, flush thoroughly with waterAvoid contact with broken skin.Do not inhale or ingest

Stop Use And Ask A Doctor If

Irritation and redness develop

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

Other Information

Store bewteen 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredient

Water, Triethanolamine, Carbomer, parfum, Tocopherylacetate (Vitamin E Acetate), Aloe Barbadensis leaf jiuce, Glycerin, CI19140, CI42090

* Please review the disclaimer below.