NDC 41250-559 Pain Relieving

First Aid Antiseptic And Pain Reliever

NDC Product Code 41250-559

NDC 41250-559-05

Package Description: 150 mL in 1 CAN

NDC Product Information

Pain Relieving with NDC 41250-559 is a a human over the counter drug product labeled by Meijer, Inc.. The generic name of Pain Relieving is first aid antiseptic and pain reliever. The product's dosage form is spray and is administered via topical form.

Labeler Name: Meijer, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Pain Relieving 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/mL
  • LIDOCAINE HYDROCHLORIDE 25 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.

  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Meijer, Inc.
Labeler Code: 41250
FDA Application Number: part348 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: 10-04-2019 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: 12-31-2020 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.

Pain Relieving 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 Cl 0.13% w/w               Lidocaine HCI 2.5% w/w

Purpose

First Aid AntisepticPain Relieving Spray

Uses

First aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor: cuts, scrapes, burns, sunburn, skin irritations

Warnings

​For external use only

​Ask A Doctor Before Use If You Have

  • •deep or puncture wounds •animal bites •serious burns

When Using This Product​

  • •do not use in or near the eyes •do not apply over large area of the body or in large quantities •do not apply over raw surfaces or blistered areas

​Stop Use And Ask A Doctor If

  • •condition worsens •symptoms persist for more than 7 days, or clear up and occur again within a few days

​Keep Out Of Reach Of Children

​If swallowed get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

  • •adults and children 2 years and older: clean the affected area. spray small amount on the area 1-3 times daily; may be covered with sterile bandage (let dry first) •children under 2 years: ask a doctor

Other Information

  • •Store at room temperature •avoid excessive heat

Inactive Ingredients

EDTA disodium, fragrance, propylene glycol, purified water, sodium hydroxide.

* Please review the disclaimer below.