NDC 73971-190 Fiori Aloe Vera Hand Sanitizer

Alcohol

NDC Product Code 73971-190

NDC 73971-190-20

Package Description: 488 mL in 1 BOTTLE, PUMP

NDC Product Information

Fiori Aloe Vera Hand Sanitizer with NDC 73971-190 is a a human over the counter drug product labeled by International Merchandise Group. The generic name of Fiori Aloe Vera Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: International Merchandise Group

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.

Fiori Aloe Vera 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 70 mL/70mL

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.

  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • WATER (UNII: 059QF0KO0R)

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: International Merchandise Group
Labeler Code: 73971
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: 07-12-2020 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.

Fiori Aloe Vera 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

Warnings

Do Not Store above 105 F May discolor some Fabrics. Harmful to wood Finishes and PlasticsFor External Use onlyFlammable, Keep away from fire or flame.When using this Product: keep out of eyes, 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 rednes appears or if condition persist for more then 72 hours.Keep out of reach of Children.If Swallowed, get medical help or contact a poison control center right away.For Hands external use only

Inactive Ingredients

Aqua/Water,Acrylates/ C 10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, AMINOMETHYL PROPANOL, ALOE BARBADENSIS LEAF EXTRACT, CI 19140,CI,42090

Directions

To decrease bacterias on the skin that could disease. Recomended for repeated used.

Keep Out Of Reach Of Children

Keep Out of Reach of Children

Alcohol

ETHYL ALCOHOL 70 %

Dosage & Administration Section

For Topical use only Fpr Hands EXTERNAL USE ONLY

For Topical use only

Indications & Usage Section

To decrease bacterias on the skin that could cause disease.

Purpose Section

Hand Sanitizer

* Please review the disclaimer below.