NDC 81601-003 Handy Pocket Sanitizer Mist

Alcohol

NDC Product Code 81601-003

NDC 81601-003-01

Package Description: 20 mL in 1 BOTTLE, SPRAY

NDC Product Information

Handy Pocket Sanitizer Mist with NDC 81601-003 is a a human over the counter drug product labeled by Cellicon Lab Inc.. The generic name of Handy Pocket Sanitizer Mist is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Cellicon Lab Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Handy Pocket Sanitizer Mist 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 .703 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)
  • OCTYLDODECETH-16 (UNII: RJV574G0DE)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
  • PURSLANE (UNII: M6S840WXG5)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • CHAMOMILE (UNII: FGL3685T2X)
  • ROSEMARY (UNII: IJ67X351P9)

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: Cellicon Lab Inc.
Labeler Code: 81601
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: 04-02-2021 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.

Handy Pocket Sanitizer Mist Product Label Images

Handy Pocket Sanitizer Mist 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 70.3% w/w

Purpose

Antimicrobial

Use

  • Hand sanitizer to help decrease bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.For external use only

Otc - When Using

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Information

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

Directions

Wet hands thoroughly with product and allow to dry without wiping

Inactive Ingredients

Water, Glycerin, Octyldodeceth-16, Fragrance, Butylene Glycol, Limonene, Salicylic Acid, Sodium Citrate, Linalool, Hexyl Cinnamal, Centella Asiatica Extract, 1,2-Hexanediol, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Portulaca Oleracea Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Oligopeptide-145

* Please review the disclaimer below.