Label: MYGRIN ROLL-ON- menthol gel

  • NDC Code(s): 49467-210-03
  • Packager: Sunascen Therapeutics LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 31, 2023

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  • ACTIVE INGREDIENTS

    Menthol, USP 3.5%


  • 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 ConsumerCare@Sunascen.com
    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
    Quality Guaranteed
    Please Recycle
    SUNASCEN THERAPEUTICS LLC 210

  • INGREDIENTS AND APPEARANCE
    MYGRIN ROLL-ON 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49467-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49467-210-031 in 1 CARTON02/05/2018
    190 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/05/2018
    Labeler - Sunascen Therapeutics LLC (078272834)
    Registrant - Sunascen Therapeutics LLC (078272834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sunascen Therapeutics LLC078272834label(49467-210)
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