Label: MINTED LEAF HEAT THERAPY RELIEF ROLL ON- capsaicin liquid

  • NDC Code(s): 73102-169-89
  • Packager: MMG Consumer Brands, 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 August 6, 2020

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

  • Drug Facts

  • Active ingredient

    Capsaicin 0.025%

    Purpose

    Topical Analgesic

  • Uses:

    • For the temporary relief of discomfort and minor aches of muscles and joints associated with strains, bruises and sprains.
    • Provides rapid cooling relief.
  • Warnings:

    For external use only.

    Do not use

    • On damaged or broken skin.
    • Do not bandage tightly.
    • If you are allergic to any ingredients in this product.

    When using this product

    • Keep out of eyes. Rinse with water to remove.
    • Use only as directed.

    Stop use and ask a doctor if

    • Rash or irritation develops and lasts.
    • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breastfeeding,

    ask a health professional before use. FDA strongly advises against the use of cannabidiol (CBD) in any form during pregnancy or while breastfeeding.

  • Directions:

    • Adults: Apply to affected area not more than 3 to 4 times daily.
  • Inactive ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arcticum Lappa (Burdock) Root Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Broad Spectrum Hemp Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunfflower) Oil, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

  • Other information:

    • Protect the product in this container from excessive heat and direct sun.
    • Do not use if seal is broken or missing.
  • Questions?

    9171 S. Dixie Hwy, Pinecrest, FL 33156.

  • Package Labeling:

    Bottle2

  • INGREDIENTS AND APPEARANCE
    MINTED LEAF HEAT THERAPY RELIEF ROLL ON 
    capsaicin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73102-169
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73102-169-8989 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/21/2020
    Labeler - MMG Consumer Brands, LLC (117036455)