NDC 78276-223 Hand Sanitizer

Alcohol

NDC Product Code 78276-223

NDC 78276-223-92

Package Description: 60 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer with NDC 78276-223 is a a human over the counter drug product labeled by Witty Cosmetics. The generic name of Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Witty Cosmetics

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.

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 620 mL/1000mL

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)

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: Witty Cosmetics
Labeler Code: 78276
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: 05-26-2020 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.

Hand Sanitizer Product Label Images

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

Ethanol 62% vlv............................................Antiseptic

Indications & Usage

  • Help reduce bacteria that can potentially cause diseasesfor use when soap & water is not available

Warnings

  • For external use onlyflammable keep away from heat or flameDo not use on children less than 2 months olds on open skin woundsWhen using this product keep out of eyes, ears and mouthin case of contact with eyes, rinse thoroughly with waterStop use and ask a doctor if irritation or rash occurs

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of childrenIf swallowed, seek medical help or contact a Poison Control Center.

Inactive Ingredient

  • Deionized water, glycerin, eucalyptus globulus leaf oil, camphor, mixed tocopherols (Vitamin E)

Dosage & Administration

2 fl oz (60ml)

Otc - Purpose

  • Help reduce bacteria that can potentially cause diseasesfor use when soap & water is not available

* Please review the disclaimer below.