Inverness Home Ear Piercing Kit
NDC 70094-004
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Inverness Home Ear Piercing Kit (benzalkonium chloride) is a OTC MONOGRAPH DRUG-approved product labeled by The Richline Group, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit. This product entry covers the primary NDC 70094-004 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
70094-004
Proprietary Name:
Inverness Home Ear Piercing Kit
Non-Proprietary Name: [1]
Benzalkonium Chloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Kit
- A packaged collection of related material.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
70094
Product Label ID:
FDA Application Number: [6]
M003
Marketing Category: [8]
OTC MONOGRAPH DRUG
Marketing Timeline
Start Marketing Date: [9]
07-21-2021
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 70094-004?
The NDC code 70094-004 is assigned by the FDA to the product Inverness Home Ear Piercing Kit. It is commonly known by its generic name, benzalkonium chloride. This pharmaceutical product is labeled by The Richline Group, Inc. and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 70094-004-03. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
For optimal results, follow these steps everyday • Clean hands thoroughly with soap before touching ears and studs. • Using cotton swabs, cleanse front and back of ears 3 times a day with Ear Care Antiseptic. Gently rotate the studs while cleansing.
DO NOT remove earrings. • Keep hair, hair spray, shampoo, soap, cosmetics, perfume, hot tubs, or use of any of the above products, rinse your ears in clear water and reapply Ear Care Antiseptic
For optimal results, follow these steps everyday. • Clean hands thoroughly with antibacterial soap before touching ears and earrings. • Using cotton swabs, cleanse front and back of ears 3 times a day with Ear Care Antiseptic. Gently rotate the earrings while cleansing. DO NOT remove earrings. • Keep hair, hair spray, shampoo, soap, cosmetics, perfume, etc. away from newly pierced ears. After shampooing, exercising, swimming, hot tubs, or use of any of the above products, rinse your ears in clear water and reapply Ear Care Antiseptic.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
- BENZALKONIUM (UNII: 7N6JUD5X6Y) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
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. The UNII codes for the inactive ingredients in this product are:
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1052949 - benzalkonium chloride 0.12 % Topical Solution
- RxCUI: 1052949 - benzalkonium chloride 1.2 MG/ML Topical Solution
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
