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| Product NDC Code | 49467-210 | ||||
|---|---|---|---|---|---|
| Drug Name | Mygrin roll-on |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 808955 | ||||
| Application Number | part348 | ||||
| Labeler Name | Sunascen Therapeutics LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Menthol, USP 3.5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Aloe barbadensis leaf extract, angelica archangelica root extract, camphor, carbomer, DMDM hydantoin, isopropyl alcohol, methylparaben, panax ginseng root extract, purified water, triethanolamine.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, backache, bruises, strains, and sprains.
Purpose
Information about the drug product’s indications for use.PURPOSE External Analgesic (Cooling Pain Relief)
Spl product data elements
Usually a list of ingredients in a drug product.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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.OTHER INFORMATION Apply product directly onto sore areas Massage well for best results Wash hands well, before and after application using cool water Store at room temperature Use before the expiration date
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have, Sensitive skin
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
KEEP OUT OF REACH OF CHILDREN If ingested, seek medical help right away or contact a Poison Control Center immediately. Call Poison Control 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS? Sunascen Therapeutics LLC Call us toll free at 1-833-SUNASCN (786-2726) Mon-Fri 9am-5pm EST. Email us at [email protected] More information is available on our website at www.sunascen.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if, Conditions worsens Symptoms persist for more than 7 days Condition clears up and reoccurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Flammable Keep away from excessive heat or open flame
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API