Label: MYCO CLINIC PAIN RELIEF- menthol cream

  • NDC Code(s): 24909-010-20, 24909-010-50
  • Packager: Aidance Skincare & Topical Solutions, 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 March 7, 2023

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

  • Active Ingredients                Purpose

    Menthol USP, 4%..........Topical analgesic

  • PURPOSE

  • Uses

    temporarily relieves minor aches and pain of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains

  • Warnings

    For external use only


    Do not use on wounds or damaged skin


    When using this product avoid contact with eyes or mucous membranes - do not bandage tightly or use with a heating pad


    Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, excessive skin irritation develops


    If pregnant or breastfeeding, ask a health professional before use.


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

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Wash hands with soap and water after use (unless applying to hands)
    children under 12 years of age: ask a doctor

  • Inactive ingredients

    Arnica Extract, Colloidal Oatmeal, Ginger Extract, Honeysuckle Oil, Jojoba Oil, MCT/Coconut Oil, Mushroom Extracts - USDA Organic (Cordyceps, Lion's Mane, Reishi, Shiitake), Purified Water, Shea Butter, Sorbic Acid, Sunflower Oil, Sweet Orange Oil, Turmeric Extract, Camphor, Emulsifying Wax

  • Questions?

    myco-clinic.com
    Questions? 401-671-6170

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    MYCO CLINIC PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    OATMEAL (UNII: 8PI54V663Y)  
    GINGER (UNII: C5529G5JPQ)  
    AQUILEGIA CANADENSIS WHOLE (UNII: 636VYW51FP)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CULTIVATED MUSHROOM (UNII: 54C8E6W6JY)  
    OPHIOCORDYCEPS SINENSIS (UNII: 8Q1GYP08KU)  
    REISHI (UNII: TKD8LH0X2Z)  
    SHIITAKE MUSHROOM (UNII: 1A64QN2D2F)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SORBIC ACID (UNII: X045WJ989B)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    TURMERIC (UNII: 856YO1Z64F)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    HERICIUM ERINACEUS FRUITING BODY (UNII: BU6Y4J4C2E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-010-5050 g in 1 TUBE; Type 0: Not a Combination Product02/24/2023
    2NDC:24909-010-20200 g in 1 TUBE; Type 0: Not a Combination Product02/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/24/2023
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-010)