NDC 79891-002 Sweet Skin Etc Hand Sanitizer Wipes

Benzalkonium Chloride

NDC Product Code 79891-002

NDC CODE: 79891-002

Proprietary Name: Sweet Skin Etc Hand Sanitizer Wipes What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzalkonium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 79891 - Dobolv (quanzhou) Paper Co., Ltd
    • 79891-002 - Sweet Skin Etc Hand Sanitizer Wipes

NDC 79891-002-01

Package Description: 1 PACKAGE in 1 BAG > 3 mL in 1 PACKAGE

NDC Product Information

Sweet Skin Etc Hand Sanitizer Wipes with NDC 79891-002 is a a human over the counter drug product labeled by Dobolv (quanzhou) Paper Co., Ltd. The generic name of Sweet Skin Etc Hand Sanitizer Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Dobolv (quanzhou) Paper Co., Ltd

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Sweet Skin Etc Hand Sanitizer Wipes 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.

  • BENZALKONIUM CHLORIDE .1 g/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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • BETAINE (UNII: 3SCV180C9W)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)

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.
  • 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: Dobolv (quanzhou) Paper Co., Ltd
Labeler Code: 79891
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: 10-30-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sweet Skin Etc Hand Sanitizer Wipes Product Label Images

Sweet Skin Etc Hand Sanitizer Wipes 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 Ingredients

Benzalkonium Chloride 0.10%

Purpose

Antiseptic

Indications And Usage

• For hand washing to decrease bacteria on the skin.   Recommended for repeat use.

Warnings

• For external use only.• Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.• Do not use if you are allergic to any one of the ingredients.• Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

Otc - Keep Out Of Reach Of Children

• Keep out of reach of children unless under adult supervision.• If swallowed, get medical help.

Directions Of Use

• Wet hands thoroughly with product and allow to dry without rinse.• Children under six years of age should be supervised when using this product.

Other Information

• Store in a dry place away from fire.

Inactive Ingredients

• Water (Aqua), Glycerol, Propanediol, Aloe Vera Extract, IPBC, Amino acid moisturizer, Vitamin E, Citric acid, Hexadecyl Pyridinium Chloride, Dodecyl polyglucoside.

* Please review the disclaimer below.