NDC 77066-777 Hand Sanitizer 70 Percent

Alcohol

NDC Product Code 77066-777

NDC 77066-777-04

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer 70 Percent with NDC 77066-777 is a a human over the counter drug product labeled by Enlightened Llc. The generic name of Hand Sanitizer 70 Percent is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Enlightened Llc

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.

Hand Sanitizer 70 Percent 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

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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)

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: Enlightened Llc
Labeler Code: 77066
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: 11-01-2020 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 70 Percent Product Label Images

Hand Sanitizer 70 Percent 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% W/W

Purpose

ANTISEPTIC

Uses

TO DECREASE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

Warnings

  • Flammable, keep away from fire or flamesFor external use onlyWhen using this productDo not use near the eyes.In case of contact, flush thoroughly with waterStop use and ask doctor ifIrritation or redness develop and persist for more than 72 hours

Otc - Keep Out Of Reach Of Children

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

Directions

Spray product on both sides of your hands and rub hands together briskly until dry. Spray on surfaces to be sanitized. Children under the age of six should be supervised when using this product. For human use only.

Inactive Ingredients

Water, Aloe Leaf Juice, Witch Hazel, Lavender – Lavandula Angsutifolia (Lavender) Essential Oil, Eucalyptus – Eucalyptus Globulus Essential Oil

* Please review the disclaimer below.