NDC 80535-0003 Sanitizer

Alcohol

NDC Product Code 80535-0003

NDC 80535-0003-1

Package Description: 100 mL in 1 BOTTLE, SPRAY

NDC Product Information

Sanitizer with NDC 80535-0003 is a a human over the counter drug product labeled by Farmacia San Arcangel, S.a De C.v. The generic name of Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Farmacia San Arcangel, S.a De C.v

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.

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.

  • ISOPROPYL 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.

  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • WATER (UNII: 059QF0KO0R)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • 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: Farmacia San Arcangel, S.a De C.v
Labeler Code: 80535
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: 10-19-2020 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.

Sanitizer Product Label Images

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

Isopropyl Alcohol 70% v/v

Purposes

Antimicrobial

Uses

Hand sanitizer to decrease virus and bacteria on the skin that could cause diseaseRecommended for repetead use

Warnings

Flammable, keep away form fire or flame

For External Use Only: Hands

For external use only: hands

When Using This Product

Keep out of eyes, do not use in or near eyes.In case of contact with eyes, flush thorougly with wateravoid contact with broken skindo not inhale or ingest

Stop Use Or Ask A Doctor If

Irritation and redness develop and condition persist for more than 72 hours

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a poison control center right away

Directions

Put enough product in your palm cover hands and rub hands together briskly until dry without wipingfor children under 6 years of age should be supervised when using

Other Information

Store below 105F (40C)may discolour certain fabricsharmful to wood finishes and plastics

Inactive Ingredients

Purified water (aqua), vegetable glycerine, d-limonene and linalool as fragance

Principal Display

70% Isopropyl hand sanitizer
Fresh scentwith terpene enhacedantibacterial protectionkills 99% of bacteria and germs70% isopropyl alcoholno ethyl alcoholno hudrogen peroxidescented with natural terpeneshelps moisturize with glycerine3.4 fluid onces (100 ml)

* Please review the disclaimer below.