NDC 80568-657 Isseey - Mist Hand Sanitizer - Over The Moon

Ethyl Alcohol

NDC Product Code 80568-657

NDC 80568-657-30

Package Description: 1 BOTTLE in 1 BOX > 30 mL in 1 BOTTLE

NDC Product Information

Isseey - Mist Hand Sanitizer - Over The Moon with NDC 80568-657 is a a human over the counter drug product labeled by Isseey. The generic name of Isseey - Mist Hand Sanitizer - Over The Moon is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Isseey

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.

Isseey - Mist Hand Sanitizer - Over The Moon 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 60 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)
  • GLYCERETH-26 (UNII: NNE56F2N14)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

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: Isseey
Labeler Code: 80568
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: 01-10-2021 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: 12-31-2022 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.

Isseey - Mist Hand Sanitizer - Over The Moon Product Label Images

Isseey - Mist Hand Sanitizer - Over The Moon 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 60%

Purpose

Antiseptic

Uses

• Apply on hand to decrease bacteria on the skin that may cause disease • recommended for repeated use.

Warnings

For external use only: hands.Flammable, keep away from fire or flame.When using this product • keep out of eye, In case of contact with eyes, flush thoroughly with water • avoid contact with broken skin • do not inhale or ingest.Stop use and ask a doctor if • irritation and redness develop • condition persists 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 a Poison Control Center right away.

Directions

• Use enough amount of product in your palm and thoroughly spread on both hands. rub into skin and allow to dry • for children under 6, must use under adult supervision. • not recommended for infants use.

Other Information

• Keep it in a cool place • away from direct sunlight and fire • Do not store above 104°F • may discolor some fabrics.

Inactive Ingredients

Purified Water, Glycereth 26, Fragrance, FD&C: (Red 40, Green 3, Blue 2).

* Please review the disclaimer below.