Cooling Epsom Rub
Menthol
Vi-jon, Inc
Human Otc Drug
NDC 0869-0494Cooling Epsom Rub also known as Menthol is a human otc drug labeled by 'Vi-jon, Inc'. National Drug Code (NDC) number for Cooling Epsom Rub is 0869-0494. This drug is available in dosage form of Granule, For Solution. The names of the active, medicinal ingredients in Cooling Epsom Rub drug includes Menthol - 11.7 mg/mL . The currest status of Cooling Epsom Rub drug is Active.
Drug Information:
| Drug NDC: | 0869-0494 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cooling Epsom Rub |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Vi-jon, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Granule, For Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MENTHOL - 11.7 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 24 Mar, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Vi-Jon, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0000000000000
|
| UPC stands for Universal Product Code. |
| UNII: | L7T10EIP3A
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0869-0494-43 | 473 mL in 1 BOTTLE, PLASTIC (0869-0494-43) | 24 Mar, 2017 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic
Product Elements:
Cooling epsom rub menthol menthol menthol water isopropyl alcohol capsicum methyl salicylate magnesium sulfate, unspecified form fd&c blue no. 1
Indications and Usage:
Use for the temporary relief of minor aches and pains of muscle joints associated with simple backache, arthritis, strains, bruises and sprains
Warnings:
Warnings for external use only
When Using:
When using this product avoid contact with the eyes do not apply to wounds or damaged skin do not bandage tightly
Dosage and Administration:
Directions adults children 2 years of age and older - apply to affected area not more than 3 to 4 times daily children under 2 years of age - consult a doctor for external use as a relaxing soak solution pour liberally into warm water no more than 4 times daily. caution: if prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician. hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician. keep out of reach of children.
Stop Use:
Stop use and ask a doctor if condtion worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
Adverse Reactions:
Adverse reactions manufactured by: vi-jon inc., st. louis, mo 63114 questions or conments? 1-888-593-0563
Package Label Principal Display Panel:
Principal display panel mountain falls relaxing soak solution cooling pain relief cooling sports rub pain relieving & soaking solution temporarily relieved pains associated with: arthritis minor muscular aches aching joints 16 fl oz (1pt) 473 ml image description