NDC 81892-117 Farewell Collection

Antiseptic Hand Soap

NDC Product Code 81892-117

NDC 81892-117-11

Package Description: 250 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Farewell Collection with NDC 81892-117 is a a human over the counter drug product labeled by Paveemol Company Limited. The generic name of Farewell Collection is antiseptic hand soap. The product's dosage form is soap and is administered via topical form.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Farewell Collection 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.

  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Paveemol Company Limited
Labeler Code: 81892
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: 06-20-2021 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.

Farewell Collection Product Label Images

Farewell Collection 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(S)

Benzalkonium chloride 0.1%

Purpose

Antiseptic

Use

To help reduce bacteria on hands.

Warnings

For external use only.

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.


Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.


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

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 1 800-222-1222

Directions

Apply on hands thoroughly, wash and rinse afterward.Children under 6 years of age should be supervised when using this product.

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Acrylates copolymer, aloe barbadensis leaf extract, chlorphenesin, cocamidopropyl betaine, disodium EDTA, glycerin, maltodextrin, panthenol, PEG-40 hydrogenated castor oil, phenoxyethanol, PPG-26-Buteth-26, purified water USP, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, tocopheryl acetate

* Please review the disclaimer below.