NDC 79861-001 Sanihealth Labs Hand Sanitizer

Ethyl Alcohol

NDC Product Code 79861-001

NDC 79861-001-04

Package Description: 4000 mL in 1 BOTTLE, SPRAY

NDC 79861-001-26

Package Description: 266 mL in 1 BOTTLE, SPRAY

NDC Product Information

Sanihealth Labs Hand Sanitizer with NDC 79861-001 is a a human over the counter drug product labeled by Sanihealth Labs Inc.. The generic name of Sanihealth Labs Hand Sanitizer is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Sanihealth Labs Inc.

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.

Sanihealth Labs 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 .7 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)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Sanihealth Labs Inc.
Labeler Code: 79861
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: 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.

Sanihealth Labs Hand Sanitizer Product Label Images

Sanihealth Labs 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 Ingredients

Ethyl Alcohol 70%v/v.Purpose: Antiseptic

Purpose

Antiseptic

Safety Instructions

Flammable, Keep away from fire and flame

Ask Doctor

Stop Use and Ask a doctor if irritation or redness develops

Keep Out Of Reach Of Children

If swallowed, get medical help or contact Poison Control right away

Other Information

Store below 15-30°C

May discolor certain fabrics or surfaces.
Avoid freezing and excessive heat

Inactive Ingredients

Water, hydrolyzed jojoba esters, glycerin, fragrance, denatonium benozate

Directions

  • Place enough product in your palm to thoroughly cover your handsRub hands together briskly until dryChildren should be supervised when using this product.For personal and occasional domestic use

Warnings

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

Uses

  • Helps reduce bacteria on the skin that could cause disease

* Please review the disclaimer below.