NDC 78064-002 Deljine Hand Sanitizer

Alcohol

NDC Product Code 78064-002

NDC 78064-002-02

Package Description: 236.6 mL in 1 BOTTLE, SPRAY

NDC Product Information

Deljine Hand Sanitizer with NDC 78064-002 is a a human over the counter drug product labeled by Deljine Cosmetics Corporation. The generic name of Deljine Hand Sanitizer is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Deljine Cosmetics Corporation

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.

Deljine 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

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: Deljine Cosmetics Corporation
Labeler Code: 78064
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: 08-22-2020 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.

Deljine 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(S)

Ethyl alcohol (Ethanol)-70 % V/V / Alcool Ethylique 70% V/V

Purpose

Antibacterial (skin) cleanser. Antiseptic (skin) cleanser. Effective in destroying (harmful) bacteria to provide antiseptic cleansing.

Use

For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria/germs. Medicated (skin) cleanser. For use when soap and water are not available.

Recent Major Changes

For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria/germs. Medicated (skin) cleanser. For use when soap and water are not available.

Warnings

Flammability warning. Keep away from open flame and sources of heat. For external use only.

Do Not Use

  • Do not use on children/infants less than 2 years of age (unless directed by a doctor/ physician/ health care practitioner/ health care provider/ health care professional). Do not use on open skin wounds

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation or rash develops.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

Directions

  • Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product. For occasional and personal domestic use.

Other Information

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

Inactive Ingredients

Water/ Aqua/Eau , Ammonium Acryloyldimethyltaurate, Glycerin, Aloe Barbadensis Leaf Juice, d-alpha-tochopheryl Acetate, fragrance (green tea coriander and mandarin)/ parfum (thé vert coriandre et mandarine).

* Please review the disclaimer below.