Label: MUSCLE AND JOINT PAIN RELIEF GR ISOLATE 750 MG- pain relief cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 28, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    This Pain Relief Cream has been formulated with methyl salicylate and menthol to help with aches and pains, and then added CBD, rosemary oil, vitamin E and more to create a truly unique cream for the wellbeing of muscles and joints.

  • Active Ingredients

    Methyl Salicylate 10% w/w. Purpose: Topical Analgesic

    Menthol 4% w/w. Purpose: Topical Analgesic

  • Purpose

    Topical Analgesic, pain relief cream

  • Use

    Pain relief cream to help reduce minor aches and pains of muscles and joints associated with: arthritis, strains, sprains, simple backaches, and bruises.

  • Do not use

    in children

    on open skin wounds

  • WHEN USING

    This product is for external use only.

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Do not bandage tightly when applying this product.

    Do not apply this product more than 4 times per day.

    Stop use and ask a doctor if irritation or rash occurs. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

  • Directions

    This product is for external use only.

    Place enough on one hand to cover the affected area and rub the area accordingly.

    Apply to affected area no more than 3 to 4 times daily.

  • Other information

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    Bentonite, Carthamus tinctorius Oleosomes, Cucumis sativus Fruit Extract, Ethylhexylglycerin, Glycerin, Hemp Derived Cannabinoid Extract, Lavandula angustifolia Oil, Persea gratissima Oil, Phenoxyethanol, Rosmarinus o­fficinalis Oil, Tocopherol, Xanthan Gum, Water.

  • Manufacturing and Distributors information

    MANUFACTURED AND DISTRIBUTED BY:

    GREEN ROADS OF FLORIDA, LLC
    601 FAIRWAY DR, DEERFIELD BEACH, FL 33441

    833-462-8922
    GREENROADS.COM

  • WARNINGS

    Avoid contact with eyes

    Do not bandage tightly

    Do not apply to wounds or damaged skin

    For external use only

  • Design and Label of BOX

    Tube Label

    Tube Label

  • Package Label Outer Box IFC

    IFC Individual Folding Carton

    IFC Label

  • Most outer BOX

    Big Container BOX

    Most outer box

  • INGREDIENTS AND APPEARANCE
    MUSCLE AND JOINT PAIN RELIEF GR ISOLATE 750 MG 
    pain relief cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78232-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CUCUMBER (UNII: YY7C30VXJT) 0.83 g  in 100 g
    WATER (UNII: 059QF0KO0R) 56.16 g  in 100 g
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) 12.5 g  in 100 g
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.83 g  in 100 g
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 g  in 100 g
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 g  in 100 g
    AVOCADO OIL (UNII: 6VNO72PFC1) 5 g  in 100 g
    CANNABIDIOL (UNII: 19GBJ60SN5) 3.02 g  in 100 g
    LAVENDER OIL (UNII: ZBP1YXW0H8) 0.83 g  in 100 g
    BENTONITE (UNII: A3N5ZCN45C) 5 g  in 100 g
    CHAMOMILE (UNII: FGL3685T2X) 0.83 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78232-002-03120 in 1 CARTON02/01/2021
    1NDC:78232-002-0230 in 1 BOX
    1NDC:78232-002-0130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/01/2021
    Labeler - Clarity Labs LLC (045246080)
    Registrant - Clarity Labs LLC (045246080)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clarity Labs LLC045246080manufacture(78232-002)