Label: CETILAR- menthol 1.4% cream

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

Drug Label Information

Updated February 4, 2025

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  • Active Ingredient

    Menthol 1.4%

  • Purpose

    Topical Analgesic

  • Use

    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. Avoid contact with eyes

    When using this product

    • Do not bandage tightly
    • do not apply to wounds or damage skin

    Stop use and ask a doctor

    • if condition worsens
    • if symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding

    ask a health professional before use

    Keep out of reach of children

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

  • Directions

    Adults and children over 12 years:

    • Apply to the affect area not more than 3 to 4 times daily
    • After applying, wash hands with soap and water

    Children 12 years or younger, consult a doctor

  • Other Information

    The product must be stored at temperature between 50-86 °F (10-30ºC), in a dry place away from light localized heat sources.

  • Inactive ingredients

    water, cetyl myristate, Glycerin, Cetyl alcohol, Glyceryl stearate, olea europea (olive ) oil unsaponifiables, cetyloleate, Butylene glycol, Caprylic capric triglyceride, prunus armeniaca (apricot) kenel oil, Beeswax, Phenoxyethanol, Triethanolamine, carbomer, fragrance, isopropyl myristate, ethylhexylglycerin, triticum vulgare (wheat) germ oil, BHT, tocopheryl acetate.

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    CETILAR 
    menthol 1.4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84797-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    APRICOT SEED OIL (UNII: 54JB35T06A)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    TRIETHANOLAMINE (UNII: 9O3K93S3TK)  
    WHEAT GERM OIL UNSAPONIFIABLES (UNII: 6AXM7XCV3D)  
    BEESWAX (UNII: 2ZA36H0S2V)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL MYRISTATE (UNII: 7OPL833Q4D)  
    PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84797-000-491 in 1 CARTON02/01/2025
    149 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/01/2025
    Labeler - PharmaNutra Usa Corp. (119066016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biofarma SRL507836496manufacture(84797-000)
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