Mygrin Roll-on
Menthol
Sunascen Therapeutics Llc
Human Otc Drug
NDC 49467-210Mygrin Roll-on also known as Menthol is a human otc drug labeled by 'Sunascen Therapeutics Llc'. National Drug Code (NDC) number for Mygrin Roll-on is 49467-210. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Mygrin Roll-on drug includes Menthol - 35 mg/mL . The currest status of Mygrin Roll-on drug is Active.
Drug Information:
| Drug NDC: | 49467-210 |
| 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: | Mygrin Roll-on |
| 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: | Sunascen Therapeutics Llc |
| 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 - 35 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: | 05 Feb, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 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, 2024 |
| 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: | Sunascen Therapeutics LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 808955
|
| 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 |
|---|
| 49467-210-03 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (49467-210-03) / 90 mL in 1 BOTTLE, WITH APPLICATOR | 05 Feb, 2018 | 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 (cooling pain relief)
Product Elements:
Mygrin roll-on menthol angelica archangelica root aloe vera leaf camphor (natural) carbomer homopolymer type c dmdm hydantoin isopropyl alcohol methylparaben asian ginseng water trolamine menthol menthol
Indications and Usage:
Indications and usage for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, backache, bruises, strains, and sprains.
Warnings:
Warnings for external use only flammable keep away from excessive heat or open flame when using this product, avoid contact with eyes or other mucous membranes do not use with other liniments such as ointments, creams, lotions, or sprays do not apply to wounds, damaged skin, irritated skin, or if excessive irritation develops do not bandage, or use with a heating pad, or similar device ask a doctor before use if you have, sensitive skin stop use and ask a doctor if, conditions worsens symptoms persist for more than 7 days condition clears up and reoccurs if pregnant or breastfeeding, ask a health professional before use. keep out of the reach of children if ingested, seek medical attention or contact a poison control center immediately at 1-800-222-1222. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product, avoid contact with eyes or other mucous membranes do not use with other liniments such as ointments, creams, lotions, or sprays do not apply to wounds, damaged skin, irritated skin, or if excessive irritation develops do not bandage, or use with a heating pad, or similar device
Dosage and Administration:
Dosage and administration (directions) adults and children 2 years of age and older: apply to the affected areas not more than four times daily. children under 2 years of age: consult a physician. shake well before each use.
Stop Use:
Stop use and ask a doctor if, conditions worsens symptoms persist for more than 7 days condition clears up and reoccurs
Package Label Principal Display Panel:
Principal display panel sunascen therapeutics llc ndc 49467-210-03 mygrin ® roll-on gel soothing menthol - cooling pain relief arthritis, back pain, sore muscles & joints non-greasy, dye-free, and non-staining with aloe 3 fl oz (90ml) shake well before each use for external use only does not contain nsaids, ibuprofen, aspirin, or salicylate "helping you turn the face of pain into a grin" ⢠tamper evident: do not use if the safety seal on the carton is broken or missing retain carton for complete product information distributed by: sunascen therapeutics llc, rockville md 20850-6252 © 2018 sunascen therapeutics llc, all rights reserved. trademarks are owned by or licensed to sunascen therapeutics llc sunascen therapeutics llc quality guaranteed please recycle sunascen therapeutics llc 210
Further Questions:
Questions or comments? sunascen therapeutics llc call us toll free at 1-833-sunascn (786-2726) mon-fri 9am-5pm est. email us at consumercare@sunascen.com more information is available on our website at www.sunascen.com