NDC 75691-101 Vapor Fresh Alcohol Based Hand Sanitizer With Aloe 62 Percent Alcohol

Alcohol

NDC Product Code 75691-101

NDC 75691-101-11

Package Description: 437 mL in 1 BOTTLE

NDC 75691-101-12

Package Description: 30 mL in 1 BOTTLE

NDC 75691-101-13

Package Description: 60 mL in 1 BOTTLE

NDC 75691-101-14

Package Description: 240 mL in 1 BOTTLE

NDC 75691-101-15

Package Description: 360 mL in 1 BOTTLE

NDC 75691-101-16

Package Description: 1000 mL in 1 BOTTLE

NDC 75691-101-17

Package Description: 1200 mL in 1 BOTTLE

NDC 75691-101-18

Package Description: 1500 mL in 1 BOTTLE

NDC 75691-101-19

Package Description: 1560 mL in 1 BOTTLE

NDC 75691-101-20

Package Description: 1920 mL in 1 BOTTLE

NDC Product Information

Vapor Fresh Alcohol Based Hand Sanitizer With Aloe 62 Percent Alcohol with NDC 75691-101 is a a human over the counter drug product labeled by Raw Athletics Llc. The generic name of Vapor Fresh Alcohol Based Hand Sanitizer With Aloe 62 Percent Alcohol is alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Raw Athletics Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Vapor Fresh Alcohol Based Hand Sanitizer With Aloe 62 Percent Alcohol 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 62 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)

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: Raw Athletics Llc
Labeler Code: 75691
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: 04-30-2020 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.

Vapor Fresh Alcohol Based Hand Sanitizer With Aloe 62 Percent Alcohol Product Label Images

Vapor Fresh Alcohol Based Hand Sanitizer With Aloe 62 Percent Alcohol 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 62%

Purpose

ANTISEPTIC

Uses

  • TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE.

Warnings

  • For external use only.Flammable. Keep away from heat and flame.When using this productKeep out of eyes. In case of contact with eyes, flush thoroughly with water.Do not inhale or ingest.Avoid contact with broken skin.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • Wet hands thoroughly with product and allow to dry without wiping.For children under 6, use only under adult supervision.Not recommended for infants.

Other Information

  • Store below 105°F (40°C). May discolor some fabrics.Harmful to wood finishes and plastics.

Inactive Ingredients

Aqua (Water), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf, Aminomethyl Propanol

* Please review the disclaimer below.