NDC 74332-003 Encore Instant Hand Sanitizing

Alcohol

NDC Product Code 74332-003

NDC 74332-003-01

Package Description: 1000 mL in 1 BAG

NDC Product Information

Encore Instant Hand Sanitizing with NDC 74332-003 is a a human over the counter drug product labeled by Encore Industrial Products, Llc. The generic name of Encore Instant Hand Sanitizing is alcohol. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 581662.

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.

Encore Instant Hand Sanitizing 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.


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.

  • CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Encore Industrial Products, Llc
Labeler Code: 74332
FDA Application Number: part333E 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: 08-26-2021 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.

Encore Instant Hand Sanitizing Product Label Images

Encore Instant Hand Sanitizing 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

Other informationMay discolor certain fabrics and surfaces.

Manufactured for:Encore Industrial Products3502 Bacor Rd. Houston, TX 770841-877-703-3044 • www.encoreindustrial.com

Otc - Active Ingredient

Active ingredientAlcohol 70% v/v

Otc - Purpose

PurposeAntiseptic

Indications & Usage

  • UsesTo decrease bacteria on the skin.Recommended for repeated use.

Warnings

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

Otc - When Using

When using this product keep out of eyes. In case of eye contact, rinse eyes with water.

Otc - Stop Use

Stop use and ask a doctorif irritation and redness develop or if condition persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

  • DirectionsApply liberally to hands to cover all surfaces.Rub hands together until dry.Supervise children under 6 years old.Not recommended for infants.

Inactive Ingredient

Inactive ingredients Water, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Fragrance, Triethanolamine, Alpha-tocopherol Acetate (Vitamin E), Aloe Barbadensis Leaf Juice, FD&C Yellow 5, FD&C Blue 1.

* Please review the disclaimer below.