NDC 76644-0001 Poly San Hand Sanitizer

Isopropyl Alcohol

NDC Product Code 76644-0001

NDC 76644-0001-1

Package Description: 3.785 L in 1 BOTTLE

NDC 76644-0001-2

Package Description: .946 L in 1 BOTTLE, SPRAY

NDC Product Information

Poly San Hand Sanitizer with NDC 76644-0001 is a a human over the counter drug product labeled by Us Polychemical Holding Corporation. The generic name of Poly San Hand Sanitizer is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1039900.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Poly San 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.

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)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • EUGENOL (UNII: 3T8H1794QW)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)

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: Us Polychemical Holding Corporation
Labeler Code: 76644
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: 05-08-2020 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 - 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.

Poly San Hand Sanitizer Product Label Images

Poly San 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

Poly San Hand Sanitizer;  Purpose

Purpose: Antimicrobial

Poly San Hand Sanitizer; Active Ingredient Section

Active Ingredient: Isopropyl Alcohol.....75%(v/v)

Poly San Hand Sanitizer; Indications & Usage Section

Use: Hand sanitizer tTo help reduce the amount of bacteria on the skin.

Poly San Hand Sanitzer; Do Not Use Section

For external use only,do not use• on children less than 2 months of age • on an open skin wound • in or near the eyes, ears or mouth In case of contact, rinse eyes thoroughly with water

Poly San Hand Sanitzer; Warnings  Section

Warnings: Flammable, keep away from fire or flame.

Poly San Hand Sanitizer Gel; Stop Use And Ask Doctor If Section

Stop use and ask Doctor if irritation appears and lasts

Poly San Hand Sanitizer; Keep Out Of Reach Of Children Section

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

Poly San Hand Sanitizer; Dosage & Administration Section

Directions: Put enough of the product in your palm to cover hands and rub hands together briskly until dry. Children under the age of 6 should be supervised when using this product

Poly San Hand Sanitizer; Inactive Ingredient Section

Inactive ingredients: Water(Aqua), glycerol, Fragrance (Parfum)

Poly San Hand Sanitizer Gel; Other Safety Information

Other information: At or below 110°F (43°C) may discolor certain fabrics or surfaces. Avoid freezing and excessive heat. Store between 59-86°F (15-30°C).

Poly San Hand Sanitzer Drug Facts Label The Following Hand Sanitizer Is Manufactured According To The 1994 Tfm For Otc Antiseptic Drug Products That Published In The Federal Register Of June 17, 1994 (59 Fr 31402).

Drug FactsActive Ingredient: Isopropanol 75% (v/v)  Purpose: Antimicrobial Use: Hand sanitizer to help reduce bacteria on skinWarnings: Flammable, keep away from fire or flame. For external use only, do not use• on children less than 2 months of age• on an open skin wound• in or near the eyes, ears or mouthIn case of contact, rinse eyes thoroughly with waterStop use and ask a doctor if irritation or rash appears and lastsKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Directions: Put enough of the product in your palm to cover hands and rub hands together briskly until dryChildren under the age of 6 should be supervised when using this productOther information: At or below 110°F (43°C) may discolor certain fabrics or surfaces.Avoid freezing and excessive heat.Store between 59-86°F (15-30°C).Inactive ingredients: Water(Aqua),glycerol, fragrance (Parfum)Poly San Hand Sanitizer Gallon Size 1.jpgPoly San Hand Sanitizer Qt size 1.jpg

* Please review the disclaimer below.