NDC 76402-418 Juniper Breeze Liquid Antimicrobial

Benzalkonium Chloride

NDC Product Code 76402-418

NDC 76402-418-02

Package Description: 3 BOTTLE, PLASTIC in 1 CARTON > 1000 mL in 1 BOTTLE, PLASTIC

NDC 76402-418-03

Package Description: 4 BOTTLE, PLASTIC in 1 CARTON > 1250 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Juniper Breeze Liquid Antimicrobial with NDC 76402-418 is a a human over the counter drug product labeled by Hillyard Gmp. The generic name of Juniper Breeze Liquid Antimicrobial is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Hillyard Gmp

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.

Juniper Breeze Liquid Antimicrobial 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 .13 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)
  • COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
  • DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
  • GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Hillyard Gmp
Labeler Code: 76402
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: 03-01-2020 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.

Juniper Breeze Liquid Antimicrobial Product Label Images

Juniper Breeze Liquid Antimicrobial 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 0.13%

Purpose

Antimicrobial

Uses

  • •Helps reduce bacteria that potentially can cause disease •Helps prevent cross-contamination by hand contact

Warnings

  • •For External Use Only •Do not contaminate water, food or feed by storage and disposal.

Keep Out Of Reach Of Children.

  • •In case of eye contact, flush with water for 15 minutes. If irritation persists, get medical attention. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

  • •Apply soap to palm of hand. •Lather and scrub hands (including fingers, wrist, and cuticles) vigorously for 60 seconds. •Rinse with water until all soap is removed from hands. •Dry completely (incomplete drying may lead to chapped skin). •Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Cocamidopropylamine Oxide, Glycerin, Propanediol, Benzyl Alcohol, (Polyquaternium-67), Phenoxyethanol, Cetrimonium Chloride, Fragrance, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Yellow #6, Aloe Barbadensis Leaf Juice, Citric Acid.

* Please review the disclaimer below.