Label: PURE EASE JOINT MUSCLE LNSTANT PAIN RELIEF- capsaicin, menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2023

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  • Drug Facts

  • Active Ingredients

    Capsaicin 0.025%

    Menthol 8.00%

    Purpose

    Topical Analgesic

  • Uses:

    • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.
    • Provides cooling pain relief.
  • Warning:

    For external use only

    Do not use:

    On damaged or broken skin.

    When using this product:

    Keep out of eyes. Rinse with water to remove

    • Do not bandage tightly.

    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 breast-feeding,

    ask a health professional before use.

  • Directions:

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

  • Other information:

    Protect the product in this container from excessive heat and direct sun.

  • Inactive Ingredients:

    Allantoin, Aloe Barbadnesis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), L-Arginine-Monohydrochloride, HCL, Amica Montana Flower Extract, Ascorbyl Phosphate (Liposomal Vitamin C), Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Saliva (Hemp) Seed Oil, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyanocobalamin (Vitamin B12), Emu Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraquariensis (Verba Mate') Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Phospholipids, Sorbitan Olivate, Stearic Acid, Urea, Xanthan Gum, Zemea (Com) Propanediol, Zingiber Officinalis (Ginger) Extract.

  • Questions?

    302-425-1815

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    PURE EASE JOINT MUSCLE LNSTANT PAIN RELIEF 
    capsaicin, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83676-435
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
    TALINEXOMER (UNII: AZC253V6FB)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HEMP (UNII: TD1MUT01Q7)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    UREA (UNII: 8W8T17847W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83676-435-0060 mL in 1 JAR; Type 0: Not a Combination Product11/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/27/2023
    Labeler - SERENU, INC. (119079642)
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