Label: MENCYLATE PAIN RELIEVING- menthol, methyl salicylate cream

  • 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 24, 2023

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  • Active ingredients


    Menthol 2.0%
    Methyl Salicylate 10.0%

    Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

  • Warnings

    For external use only.

    Do not

    • apply on wounds or damaged skin • bandage tightly

    When using this product

    • avoid contact with the eyes or mucous membranes • do not use other than as directed

    Stop use and ask a doctor if

    • condition worsens • 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.

  • Directions

    • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. • Children under 12 years of age: consult a doctor.

  • Other information

    • Store at controlled room temperature 20°-25°C (68°-77°F).

  • Inactive ingredients:

    Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Borago Officinalis Seed Oil, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, DL-Alpha-Tocopheryl Acetate, Eucalyptus Globulus Leaf Oil, Fragrance, Fructose, Phenoxyethanol, Propylene Glycol, Squalane, Stearic Acid, Stearyl Alcohol, Sodium Hydroxide, Tetrasodium EDTA, Vitis Vinifera (Grape) Seed Oil.

  • Mencylate TM

    Manufactured in the USA by:
    PureTek Corporation
    Panorama City, CA 91402
    Questions? Call toll-free: 1-877-921-7873 Label

  • INGREDIENTS AND APPEARANCE
    MENCYLATE  PAIN RELIEVING
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-215
    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) MENTHOL20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-215-0559 mL in 1 JAR; Type 0: Not a Combination Product03/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/24/2023
    Labeler - PureTek Corporation (785961046)
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