NDC 80535-0001 Hand Sanitizer

Alcohol

NDC Product Code 80535-0001

NDC 80535-0001-1

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 80535-0001-2

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC 80535-0001-3

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Hand Sanitizer with NDC 80535-0001 is a a human over the counter drug product labeled by Farmacia San Arcangel, S.a. De C.v.. The generic name of Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

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

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 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 65 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.

  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PEPPERMINT OIL (UNII: AV092KU4JH)

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: 09-07-2020 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 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 v/v- 60-80%

Purposes

Antimicrobial

Uses

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

Warnings

For external use only: handsFlammable, keep away form fire and flame

When Using This Product

Keep out of ayes, do not use in or near the eyesIn case of contact with eyes, flush thorougly with waterAvoid contact with broken skinDo not inhale or ingest

Keep out of ayes, do not use in or near the eyesIn case of contact with eyes, flush thorougly with waterAvoid contact with broken skinDo not inhale or ingest

Stop Use And Ask A Doctor If

Irritation and redness developCondition persists for more than 72 hours

Keep Out Of Reach Of Children

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

Directions

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

Other Information

Store below 105 F 40CMary discolour certain fabricsharmful to wood finishes and plastics

Inactive Ingredients

Purified water (aqua), vegetable glycerin, carboxymethyl cellulose, hydroxypropyl methylcellulose HPMC, and pepper mint oild and vitamine E

Principal Display

Natural ingredients
MintHand sanitizer geleliminates 99.9% of germsvitamine E hands softcontain mosturizers*e coli and S. areusHO3parabensmethanolformaldehydetriethanolaminecarbopolfree

* Please review the disclaimer below.