Arctic Relief Pain Relieving

Menthol, Unspecified Form


Stratus Pharmaceuticals Inc
Human Otc Drug
NDC 58980-618
Arctic Relief Pain Relieving also known as Menthol, Unspecified Form is a human otc drug labeled by 'Stratus Pharmaceuticals Inc'. National Drug Code (NDC) number for Arctic Relief Pain Relieving is 58980-618. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Arctic Relief Pain Relieving drug includes Menthol, Unspecified Form - 5 g/113.4g . The currest status of Arctic Relief Pain Relieving drug is Active.

Drug Information:

Drug NDC: 58980-618
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: Arctic Relief Pain Relieving
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, Unspecified Form
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Stratus Pharmaceuticals 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 - 5 g/113.4g
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: 07 Jun, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 2025
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:STRATUS PHARMACEUTICALS INC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:415975
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
58980-618-32907.2 g in 1 BOTTLE, PUMP (58980-618-32)07 Jun, 2021N/ANo
58980-618-401 TUBE in 1 BOX (58980-618-40) / 113.4 g in 1 TUBE07 Jun, 2021N/ANo
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 cooling pain reliever

Product Elements:

Arctic relief pain relieving menthol, unspecified form menthol, unspecified form menthol, unspecified form camphor (synthetic) carbomer homopolymer type c (allyl pentaerythritol crosslinked) ilex paraguariensis leaf isopropyl alcohol aloe vera leaf arctium lappa root boswellia serrata whole calendula officinalis flower green tea leaf methylparaben water silicon dioxide trolamine melissa officinalis whole

Indications and Usage:

Uses temporary relief from minor aches and pains of sore muscles & joints associated with arthritis backache strains sprains.

Warnings:

Warnings for external use only. flammable: keep away from excessive heat or open flame. ask a doctor before use if you have sensitive skin. when using this product avoid contact with the eyes or mucous membranes do not apply to wounds or damaged skin do not use with other ointments, creams, sprays or liniments do not apply to irritated skin or if excessive irritation develops do not bandage wash hands after use with cool water do not use with a heating pad or device stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and recur. if pregnant or breast-feeding , ask a health professional before use. keep out of reach of children: if accidentally ingested, get medical help or contact a poison control center immediately.

When Using:

When using this product avoid contact with the eyes or mucous membranes do not apply to wounds or damaged skin do not use with other ointments, creams, sprays or liniments do not apply to irritated skin or if excessive irritation develops do not bandage wash hands after use with cool water do not use with a heating pad or device

Dosage and Administration:

Directions adults and children 2 years of age and older: rub a thin film over affected areas not more than 4 times daily; massage not necessary. children under 2 years of age: consult physician.

Stop Use:

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

Package Label Principal Display Panel:

Principal display panel - 113.4 g tube box ndc 58980-618-40 net wt. 4 oz. / 113.4 g stratus pharmaceuticals inc arctic relief pain relieving gel • greaseless • stainless • vanishing scent penetrating, long-lasting pain relief from: arthritis, sore muscles, joints and back pain. principal display panel - 113.4 g tube box

Further Questions:

Questions or comments? call customer service at 800-442-7882


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.