NDC 63146-314 Chemstar Retail Hand Sanitizer

Alcohol

NDC Product Code 63146-314

NDC 63146-314-09

Package Description: 1200 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Chemstar Retail Hand Sanitizer with NDC 63146-314 is a a human over the counter drug product labeled by Kay Chemical Company. The generic name of Chemstar Retail Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Kay Chemical Company

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.

Chemstar Retail 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 60 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.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • MYRISTYL ALCOHOL (UNII: V42034O9PU)

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: Kay Chemical Company
Labeler Code: 63146
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: 05-27-2021 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.

Chemstar Retail Hand Sanitizer Product Label Images

Chemstar Retail 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

Active Ingredient

Ethanol 60% by volume

Purpose

Antiseptic handwash

Uses

  • For handwashing to decrease bacteria on the skin

Warnings

  • For external use onlyFLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge

Do Not Use

  • In eyesOn deep cuts or puncture wounds

When Using This Product

  • If in eyes, rinse promptly and thoroughly with waterDiscontinue use if irritation and redness develop

Otc - Ask Doctor

Stop use and ask a doctor if eye or skin irritation or redness occurs 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 right away.

Directions

  • Apply liberal amount into handSpread by rubbing hands togetherRub to dryness with attention to area around nails and between fingers

Other Information

  • THIS PRODUCT IS NOT A SUBSTITUTE FOR HANDWASHINGWITH SOAP AND WATERFor additional information, see Safety Data Sheet (SDS)EMERGENCY HEALTH INFORMATION: In the US, call (877) 231-2615 or call collect 0 (952) 853-1713

Inactive Ingredient

Inactive ingredients water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol

Otc - Questions

Questions? call 1-800-529-5458

* Please review the disclaimer below.