NDC 76557-001 Hand Sanitizer Wipes

Juniper Clean

NDC Product Code 76557-001

NDC 76557-001-01

Package Description: 110 mg in 1 CANISTER

NDC 76557-001-02

Package Description: 245 mg in 1 CANISTER

NDC 76557-001-03

Package Description: 35 PATCH in 1 CANISTER > 3.14 mg in 1 PATCH

NDC 76557-001-04

Package Description: 75 PATCH in 1 CANISTER > 3.14 mg in 1 PATCH

NDC 76557-001-05

Package Description: 72 PATCH in 1 PACKAGE > 3.14 mg in 1 PATCH

NDC Product Information

Hand Sanitizer Wipes with NDC 76557-001 is a a human over the counter drug product labeled by Kync Design Llc. The generic name of Hand Sanitizer Wipes is juniper clean. The product's dosage form is cloth and is administered via cutaneous; topical form.

Labeler Name: Kync Design Llc

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.

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 .125 mg/100mg
  • BENZALKONIUM CHLORIDE .125 mg/100mg

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.

  • CLOVE (UNII: K48IKT5321)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Cutaneous - Administration to the skin.
  • 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.
  • Cutaneous - Administration to the skin.
  • 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: Kync Design Llc
Labeler Code: 76557
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: 07-10-2020 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.

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

Other

SPL UNCLASSIFIED SECTION

Active Ingredient(S)

Benzalkonium Chloride (CAS NO: 68424-85-1), 0.125% .

Purpose

Antimicrobial

Use

Hand sanitizing wipes help remove bacteria from hands and kill 99.99% of germs. Removes dirt to help with health and cleanliness.

Warnings

Use on hands only.

Do Not Use

If you are allergic to any of the ingredients.

Stop Use And Ask A Doctor

If irritation or rash occurs.

Do Not Use In Or Near The Eyes.

If contact occurs rinse with plenty of water. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical advice/attention.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center immediately.

Directions

To Open Package: Flip open dispensing cap. Locate wipe at center of roll and pull through small openning in lid. For best results dispense wipes at an angle. Wet hands thoroughly with product and allow to dry. When finished, snap lid cap shut to retain moisture. Discard wipe in trash receptacle after use. Do not flush.

Inactive Ingredients

Water(Aqua), Ethanol, Decyl Glucoside, Glycerine, Aloe Vera Extract, D-Panthenol, Fragrance (Perfume)

* Please review the disclaimer below.