NDC 52313-1112 Meijer Cold Therapy Pain Relief 360

Cold Therapy Muscle

NDC Product Code 52313-1112

NDC 52313-1112-1

Package Description: 85 g in 1 CAN

NDC Product Information

Meijer Cold Therapy Pain Relief 360 with NDC 52313-1112 is a a human over the counter drug product labeled by Sklar Bov Solutions Inc. The generic name of Meijer Cold Therapy Pain Relief 360 is cold therapy muscle. 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 Cold Therapy Pain Relief 360 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 105 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.

  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • WATER (UNII: 059QF0KO0R)
  • CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CHAMOMILE (UNII: FGL3685T2X)
  • JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9)
  • ALCOHOL (UNII: 3K9958V90M)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

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: 05-04-2020 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 Cold Therapy Pain Relief 360 Product Label Images

Meijer Cold Therapy Pain Relief 360 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

Active Ingredient PurposeMenthol 10.5% Cooling Pain Relief

Otc - Purpose

UseTemporary relief of minor aches and pains of sore muscles and joints associated with arthritis, backaches, strains and springs.

Warnings

WarningsFor external use onlyFlammableKeep away from excessive heat or open flame. Contents umder pressure. Do not store at temperatures above 120ºF.

Indications & Usage

When using the product avoid contact with the eyes or mucous membranes.,do not apply to wounds or damaged skin, do
not apply to the irritated skin or if excessive irritation develops, do not bandage, do not use with heating pad of device.Stop and ask a doctor if, condition worsens or if symptoms persist for more than 7 days or clear up and occur again with a fewdaysIf pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of Children. Iff accidentally ingested get medical help of contacat a Poison Control Center immediately.

Dosage & Administration

Directions , Adults and Children 12 yearsof age and older.Spray on the affected areas not more that 4 times daily., massage not necessary.
Children under 12 years of age. Consult a doctor

Warnings And Precautions

Other informatonStore in a cool dry place with lid closed tightly

Inactive Ingredient

Inactive Ingredients Alcohol denat. arnica montana flower extract, calendula officinalis flower extract, camellia sinensis leaf extract, chamomillx recuitita (matricaria) flower extract, dimethyl sulfone (MSM), ecinacea angustifolia extract, ilex paraguariensis leaf extract, isopropyl myristate, juniperus communis fruit extract, water

Otc - Questions

Questions 1-800-255-3924

* Please review the disclaimer below.