NDC 52313-1110 Meijer Medicated Cold And Hot Pain Relieving

Cold And Hot

NDC Product Code 52313-1110

NDC CODE: 52313-1110

Proprietary Name: Meijer Medicated Cold And Hot Pain Relieving 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: Cold And Hot 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

  • 52313 - Sklar Bov Solutions Inc
    • 52313-1110 - Meijer Medicated Cold And Hot Pain Relieving

NDC 52313-1110-1

Package Description: 113 g in 1 CAN

NDC Product Information

Meijer Medicated Cold And Hot Pain Relieving with NDC 52313-1110 is a a human over the counter drug product labeled by Sklar Bov Solutions Inc. The generic name of Meijer Medicated Cold And Hot Pain Relieving is cold and hot. The product's dosage form is spray and is administered via topical form.

Labeler Name: Sklar Bov Solutions 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.

Meijer Medicated Cold And Hot 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.

  • MENTHOL 160 mg/g

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)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Sklar Bov Solutions Inc
Labeler Code: 52313
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: 05-05-2020 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.

Meijer Medicated Cold And Hot Pain Relieving Product Label Images

Meijer Medicated Cold And Hot 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

Otc - Purpose

UseTemporarly releaves minor aches and pains of muscles and joints associated wotj artjrotos, , simple backaches, strains, bruses,and sprains

Otc - Active Ingredient

Active Ingredient PurposeMenthol 16% Topical Analgesic

Warnings

WarningsFor external use onlyFlammableKeep away for from fire or flame. Do not puncture or incinerate.Contents under pressure. Do not store at temperatures above 120ºF.

Indications & Usage

When using this product, avoid contact with eyes and mucouse membranes.
Do not apply to wounds or damaged skin Do not bandage tightly Use only as directedStop use and ask a doctor if condition worsens, symptoms presist for more than 7 days, or clears up and occur again within
a few days. needed for more that a weeklIf pregnant or breastfeeding ask a health professional before use.

Dosage & Administration

Directions , Adults and Children over 12 years oldSpray affected area with desired amount of product,
Repeat at needed but no more that 3 - 4 times dailiyChildren 12 years of younger. Consult a physician

Inactive Ingredient

Inactive IngredientsAlcohol denat. glycerin, propylene glycol, water

Otc - Keep Out Of Reach Of Children

Keep our of reach of Children. If ingested get medical help or contact a Poison Control Center immediatly

Otc - Questions

Questions 1-800-255-3924

* Please review the disclaimer below.