Mountain Ice Sports Recovery
Menthol
Mountainside Medical Equipment, Inc.
Human Otc Drug
NDC 72793-201Mountain Ice Sports Recovery also known as Menthol is a human otc drug labeled by 'Mountainside Medical Equipment, Inc.'. National Drug Code (NDC) number for Mountain Ice Sports Recovery is 72793-201. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Mountain Ice Sports Recovery drug includes Menthol, Unspecified Form - 6 g/100mL . The currest status of Mountain Ice Sports Recovery drug is Active.
Drug Information:
| Drug NDC: | 72793-201 |
| 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: | Mountain Ice Sports Recovery |
| 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: | Mountainside Medical Equipment, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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, UNSPECIFIED FORM - 6 g/100mL
|
| 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: | 01 Nov, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 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: | Mountainside Medical Equipment, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 415976
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 72793-201-01 | 6 mL in 1 PACKET (72793-201-01) | 01 Nov, 2022 | N/A | No |
| 72793-201-03 | 946 mL in 1 BOTTLE, PUMP (72793-201-03) | 01 Nov, 2022 | N/A | No |
| 72793-201-04 | 99 mL in 1 BOTTLE, WITH APPLICATOR (72793-201-04) | 01 Nov, 2022 | N/A | No |
| 72793-201-05 | 118 mL in 1 TUBE (72793-201-05) | 01 Nov, 2022 | 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 external analgesic
Product Elements:
Mountain ice sports recovery menthol menthol, unspecified form menthol, unspecified form aloe vera leaf arnica montana flower indian frankincense oil green tea leaf carbomer homopolymer, unspecified type camphor oil turmeric oil dimethyl sulfone glycyrrhizinate dipotassium ethylhexylglycerin eucalyptus oil glycerin isopropyl alcohol arginine limonene, (+)- magnesium sulfate, unspecified form tea tree oil mentha spicata oil niacinamide asian ginseng phenoxyethanol polysorbate 20 .alpha.-tocopherol acetate trolamine water fd&c blue no. 1
Indications and Usage:
Uses: temporary relief of minor aches and pains of muscles and joints associated with osteoarthritis, rheumatoid arthritis, muscle strains, and sprains.
Warnings:
Warnings: for external use only. flammable: keep away from excessive heat or open flame. avoid contact with eyes or mucous membranes. when using this product: ⢠do not apply to wounds, damaged skin, or irritated skin. ⢠do not apply with other creams, ointments, sprays or liniments. stop use and ask a doctor if: conditions worsen, skin irritation develops, or condition does not improve after 7 days. keep out the reach of children. if accidentally swallowed, seek medical attention immediately or contact poison control center right away.
When Using:
When using this product: ⢠do not apply to wounds, damaged skin, or irritated skin. ⢠do not apply with other creams, ointments, sprays or liniments.
Dosage and Administration:
Directions: adults and children 2 years of age or older. rub on the affected area evenly no more than 4 times per day. children under 2 years of age: consult with your doctor.
Stop Use:
Stop use and ask a doctor if: conditions worsen, skin irritation develops, or condition does not improve after 7 days.
Package Label Principal Display Panel:
Principal display panel sport muscle pain relief therapy gel mountain ice ginseng, arnica, turmeric, vitamin b3, boswellia indian frankincense oil, green tea extract, msm, vitamin e, aloe vera, tea tree oil, menthol 6%, l-arginine amino acid, licorice root extract, eucalyptus leaf, spearmint oil 4 fl oz (118 ml) questions? 1-888-687-4334 manufactured in the usa distributed by a service-disabled veteran-owned family business located in upstate ny mountainside medical equipment marcy, ny 13403 label image-01
Principal display panel muscel therapy gel mountain ice sports recovery gel vegan gluten free \ Ç / gluten free \ Ç / made with natural ingredients mountain ice 3 fl oz (99 ml) made in the usa by a family owned service-disabled veteran-owned small business mountain ice 9262 old river road marcy, ny 13403 usa www.mountain-ice.com if pregnant or breastfeeding: ask a health professional before use label image-02