Label: TRICYLATE- menthol, unspecified form and methyl salicylate cream

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

Drug Label Information

Updated June 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Menthol 2%Topical Analgesic
    Methyl Salicylate 10%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.

  • Warnings

    For external use only

    Do not use

    • Do not use otherwise than as directed.

    Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    When using this product

    • Avoid contact with eyes.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breastfeeding, 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: Do not use; consult a doctor.
  • Other information

    Store at temperatures less than 30°C (86°F).

  • Inactive ingredients

    Alkyl (C12-15) benzoate, butylparaben, Carica papaya (papaya) fruit extract, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, dimethicone, disodium EDTA, emulsifying wax, ethylparaben, glycerin, glycerol stearate, hydrogenated polydecene, hydroxyethyl cellulose, isobutylparaben, methylparaben, PEG 100 stearate, phenoxyethanol, propylene glycol, propylparaben, purified water, sodium lactate, sodium polyacrylate, trideceth-6, xanthan gum.

  • Questions/Comments?

    (210) 944-6920

  • PRINCIPAL DISPLAY PANEL - 85 G Pouch Tube Label

    Tear at notch to open. Do not use if seal is broken.

    NDC 73352-575-04

    TRIFLUENT
    PHARMA™

    Tricylate™

    2% Menthol
    10% Methyl Salicylate

    Topical Analgesic Cream

    NET WT. 3 OZ. (85 G)

    PRINCIPAL DISPLAY PANEL - 85 G Pouch Tube Label
  • INGREDIENTS AND APPEARANCE
    TRICYLATE 
    menthol, unspecified form and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73352-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM20 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PAPAYA (UNII: KU94FIY6JB)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73352-575-041 in 1 POUCH06/17/2024
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01706/17/2024
    Labeler - Trifluent Pharma LLC (117167281)
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