Active Ingredients
Menthol, USP 3.5%
Mygrin Roll-on
FDA Label NDC 49467-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sunascen Therapeutics Llc for the product Mygrin Roll-on (NDC 49467-210). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, indications and usage, warnings, flammable, when using this product,, ask a doctor before use if you have,, stop use and ask a doctor if,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic (Cooling Pain Relief)
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
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.
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.
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.
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
Inactive Ingredients
Aloe barbadensis leaf extract, angelica archangelica root extract, camphor, carbomer, DMDM hydantoin, isopropyl alcohol, methylparaben, panax ginseng root extract, purified water, triethanolamine.
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
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
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Sunascen Therapeutics Llc 210 (49467210 20190101)
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