MYGRIN ROLL-ON (MENTHOL) GEL [SUNASCEN THERAPEUTICS LLC]

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MYGRIN ROLL-ON (MENTHOL) GEL [SUNASCEN THERAPEUTICS LLC]
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NDC 49467-210-03
Set ID d55e92fa-0cbb-4510-bcfc-3e13847abf2d
Category HUMAN OTC DRUG LABEL
Packager Sunascen Therapeutics LLC
Generic Name
Product Class
Product Number
Application Number PART348
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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

    NDC 49467-210-03

  • 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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