NDC 79426-105 Meli Hands Hand Sanitizer

Ethyl Alcohol

NDC Product Code 79426-105

NDC 79426-105-01

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC 79426-105-02

Package Description: 60 mL in 1 BOTTLE, SPRAY

NDC 79426-105-08

Package Description: 237 mL in 1 BOTTLE, SPRAY

NDC 79426-105-16

Package Description: 473 mL in 1 BOTTLE, SPRAY

NDC Product Information

Meli Hands Hand Sanitizer with NDC 79426-105 is a a human over the counter drug product labeled by Meli Hands, Llc. The generic name of Meli Hands Hand Sanitizer is ethyl alcohol. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1041849.

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.

Meli Hands 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • ETHYL BUTYRATE (UNII: UFD2LZ005D)
  • .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PIPERONAL (UNII: KE109YAK00)
  • HEXYL ACETATE (UNII: 7U7KU3MWT0)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • VANILLIN (UNII: CHI530446X)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Meli Hands, Llc
Labeler Code: 79426
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: 11-13-2020 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 - 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.

Meli Hands Hand Sanitizer Product Label Images

Meli Hands 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

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

To help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from flame or high heat.When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or redness develop.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Spray or pump a small amount into the palm of your dry hands, rub and wait until evaporated. Children under 6 should be supervised when using this product.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzyl Benzoate Natural, Ethyl Butyrate Natural, Gamma Octalactone Natural, Glycerin, Heliotropine Natural, Hexyl Acetate Natural, Isopropyl Myristate, Neobee M-5 Natural Solvent, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Peppermint Oil, Tocopheryl Acetate, Vanillin Natural, Water

* Please review the disclaimer below.