NDC 61577-4200 Ne Mexico Aging Long Term Services Department Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 61577-4200

NDC CODE: 61577-4200

Proprietary Name: Ne Mexico Aging Long Term Services Department Hand Sanitizer 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

  • 61577 - Sombra Cosmetics
    • 61577-4200 - Ne Mexico Aging Long Term Services Department Hand Sanitizer

NDC 61577-4200-8

Package Description: 237 g in 1 BOTTLE, PLASTIC

NDC Product Information

Ne Mexico Aging Long Term Services Department Hand Sanitizer with NDC 61577-4200 is a a human over the counter drug product labeled by Sombra Cosmetics. The generic name of Ne Mexico Aging Long Term Services Department Hand Sanitizer is benzalkonium chloride. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2569179.

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 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.

Ne Mexico Aging Long Term Services Department Hand Sanitizer 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.


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)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GUAR GUM (UNII: E89I1637KE)
  • LEMON OIL (UNII: I9GRO824LL)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
  • CHAMOMILE (UNII: FGL3685T2X)
  • YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)
  • FILIPENDULA RUBRA WHOLE (UNII: MT26BL24AZ)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sombra Cosmetics
Labeler Code: 61577
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: 09-03-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Ne Mexico Aging Long Term Services Department Hand Sanitizer Product Label Images

Ne Mexico Aging Long Term Services Department Hand Sanitizer 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 0.15%

Uses

To decrease bacteria and viruses on the skin that could cause disease. Recommended for repeated use.

Warnings

For external use only: hands.

Do Not Use

Avoid contact with broken skin. Do not inhale or ingest. Children under 6, use onlyunder adult supervision. Not recommended for infants.

When Using

When using this product, keep out of the eyes. In case of contact with eyes, flush thoroughly with water.

Stop Use

Stop use if irritation and redness develop or if condition persists for more than 72 hours.

Keep Out Of Reach Of Childrenn

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping. For children inder 6, use only under adult supervision.

Storage And Handling

Store away from oxidizing agents. Do not store above 100 C.

Inactive Ingredients

Purified water, glycerin, cyamopsis tetragonoloba (Guar) gum, citrus limon (lemon) peel oil, hamamelis virginiana (witch hazel) leaf extract, camellia sinensis (green tea) leaf extract, champmilla recutita (matricaria) flower extract, rosa damascena (rose) flower waterr, aloe barbadensis leaf juice, yucca schidigera stem extract, filipendula ulmaria (queen of the prairie) extract, phenoxyethanol, caprylyl glyol, citric acid

Purpose

Anitmicrobial

* Please review the disclaimer below.