Label: REINA CBD INFUSED TOPICAL PAIN RELIEF- methyl salicylate, menthol lotion

  • 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 30, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENTS:

    Methyl Salicylate 10%

    Menthol 4%

    PURPOSE

    Topical Analgesic

  • USES:

    Temporarily relieves inflammation, mild aches and pains of muscle joints.

  • WARNINGS:

    Only for external use.

    Do not use:

    on open wounds, cuts damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucosus membranes.

    Consult your physician:

    • if pain is persistent or worsens or if using any other topical pain products.
    • Call poison control if swallowed. If contact with eyes occurs, rinse eyes thoroughly with cold water.

    Keep out of reach of children.

    Consult physician for children under 12.

  • DIRECTIONS: (Store in a cool dry place)

    Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately aftwards and avoid contact with eyes.

  • INACTIVE INGREDIENTS:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cannabis Sativus (Full Spectrum Hemp) Seed Oil, Capsaicin, Chamomilla Recutita (Chamomile) Extract, Cetearyl Olivate, Cetyl Alcohol, Cetyl Myristoleate, Chondroitin Sulfate, Gluconolactone, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) oil, Ilex Paraguariensis (Yerba Mate') Extract, Isopropyl Myristate, Methylsulfonylmethane (MSM), Magnesium Sulfate, Pantothenic Acid (Vitamin B5), Pyridoxine (Vitamin B6), Salix Nigra (Willow) Bark Extract, Sodium Benzoate, Sorbitan Olivate, Squalane, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    REINA CBD INFUSED TOPICAL PAIN RELIEF 
    methyl salicylate, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73588-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LICORICE (UNII: 61ZBX54883)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SQUALANE (UNII: GW89575KF9)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73588-068-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/20/2020
    Labeler - Reina Wellness LLC (117245556)