NDC 47682-318 Green Guard Isopropyl Alcohol 70%

Isopropyl Alcohol

NDC Product Code 47682-318

NDC 47682-318-02

Package Description: .0591 L in 1 BOTTLE, SPRAY

NDC Product Information

Green Guard Isopropyl Alcohol 70% with NDC 47682-318 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Green Guard Isopropyl Alcohol 70% is isopropyl alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Green Guard Isopropyl Alcohol 70% 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 550.2 g/L

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)

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: Unifirst First Aid Corporation
Labeler Code: 47682
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: 06-01-2021 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.

Green Guard Isopropyl Alcohol 70% Product Label Images

Green Guard Isopropyl Alcohol 70% 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredientIsopropyl Alcohol 70.0%

Otc - Purpose

PurposeFirst aid antiseptic

Indications & Usage

Usesfirst aid to help decrease the risk of infection in minor cuts, scrapes, and burns

Warnings

WarningsFor external use only.Flammable, keep away from fire or flame

Otc - Do Not Use

  • Do not usein the eyes or apply over a large areas of the bodylonger than 1 week unless directed by a doctor

Otc - Ask Doctor

  • Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

  • Stop use and consult a doctor ifthe condition persists or gets worse

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.

Dosage & Administration

  • Directionsclean affected areaspray a small amount of this product on the area 1 to 3 times dailymay be covered with a sterile bandageif bandaged, let dry first

Other Safety Information

  • Other informationstore at room temperaturedoes not contain, nor is intended as a substitute for grain or ethyl alcoholyou may report a serious adverse reaction to this product to 1-800-869-6970

Inactive Ingredient

Inactive ingredient water

Otc - Questions

Questions or comments? 1-800-869-6970

* Please review the disclaimer below.