NDC 50157-515 Antibacterial Moisturizing Rosemary Mint Aloe And Vitamin E

Benzalkonium Chloride

NDC Product Code 50157-515

NDC 50157-515-10

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 50157-515-23

Package Description: 236 mL in 1 BOTTLE, PLASTIC

NDC 50157-515-37

Package Description: 3780 mL in 1 BOTTLE, PLASTIC

NDC 50157-515-44

Package Description: 443 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Antibacterial Moisturizing Rosemary Mint Aloe And Vitamin E with NDC 50157-515 is a a human over the counter drug product labeled by Brands International Corporation. The generic name of Antibacterial Moisturizing Rosemary Mint Aloe And Vitamin E is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Brands International Corporation

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.

Antibacterial Moisturizing Rosemary Mint Aloe And Vitamin E 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 1.3 mg/mL

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: Brands International Corporation
Labeler Code: 50157
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: 01-26-2021 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 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.

Antibacterial Moisturizing Rosemary Mint Aloe And Vitamin E Product Label Images

Antibacterial Moisturizing Rosemary Mint Aloe And Vitamin E 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

Otc - Active Ingredient

Benzalkonium Chloride - 0.13%

Otc - Purpose

Purpose - Antiseptic Skin cleanser

Indications & Usage

Effective in destroying (harmful) bacteria to provide antiseptic cleansing

Warnings

Warnings For external use only

Otc - Stop Use

Stop use and ask a doctor if irritation or redness develops

Otc - When Using

  • When using this productavoid contact with eyes. If contact occurs, rinse eye thoroughly with water

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children :If swallowed get medical help or contact a Poison Control Center right away

Dosage & Administration

  • Directions:For occasional and personal domestic useSupervise children when they use this product.Lather in hands with water for at least 30 seconds.Rinse well.

Inactive Ingredient

Lauramidopropylamine oxide, Lauryl Glucoside, PEG-150 distearate, Glycol Stearate, Perfume, PEG-7 glycerly cocoate, Cetrimonium Chloride, Citric Acid, Glycerin, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Isopropyl myristate, Tocopheryl Acetate.Yellow 6,Blue 1.

Other Safety Information

  • Store below 59F-86FMay discolor certain fabrics or surfaces.

* Please review the disclaimer below.