NDC 71766-002 Hand Sanitizer Wipes

Benzalkonium Chloride

NDC Product Code 71766-002

NDC Code: 71766-002

Proprietary Name: Hand Sanitizer Wipes Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 71766 - Hangzhou Linkeweier Daily Chemicals Co., Ltd.
    • 71766-002 - Hand Sanitizer Wipes

NDC 71766-002-01

Package Description: 60 BOTTLE in 1 CARTON > 30 GEL in 1 BOTTLE

NDC Product Information

Hand Sanitizer Wipes with NDC 71766-002 is a a human over the counter drug product labeled by Hangzhou Linkeweier Daily Chemicals Co., Ltd.. The generic name of Hand Sanitizer Wipes is benzalkonium chloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Hangzhou Linkeweier Daily Chemicals Co., Ltd.

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 Additional informationCallout TooltipWhat 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.


Hand Sanitizer Wipes Active Ingredient(s)

Additional informationCallout TooltipWhat 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 .13 g/1001

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hangzhou Linkeweier Daily Chemicals Co., Ltd.
Labeler Code: 71766
FDA Application Number: part333A Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-20-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Hand Sanitizer Wipes Product Label Images

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 Ingredient

Benzalkonium chloride 0.13%

Purpose

Antimicrobial

Use

For hand sanitizing to decrease bacteria on the skin.

Warning

Flammable. Keep away from heat and flame.For External use only.Do not use in eyes. In case of contact, rinse thoroughly with water.Stop use & ask doctor if rash/redness or irritation appears/developsand persist for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach from children except under adult supervision.If swallowed, get medical help or contact a Poison Control Center

Directions

Slowly peel back label and use one wipe. Reseal, keep closed to prevent evaporation. Thoroughly wipe hands, allow to dry out rinsing. Discard after single useOther information Do not flush down toilet. Keep away from sunlight. Store at room temperature 20°-25°Celsius (68°-77° Fahrenheit) May discolor certain fabrics

Inactive Ingredient

Aqua, Glycerin, Phenoxyethanol, Benzoic Acid, Polysorbate 20,Aloe Barbadensis Leaf Juice, Sodium Citrate

* Please review the disclaimer below.

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