Label: ZPOL ULTRA- menthol, methyl salicylate cream

  • NDC Code(s): 55715-008-01, 55715-008-02, 55715-008-03
  • Packager: Laboratorios Zepol S.A.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 14, 2024

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  • Drug Facts

  • Active ingredients

    Menthol 4%Methyl Salicylate 10%

    Purpose

    Active IngredientsPurpose
    Menthol 2.84%Topical Analgesic
    Methyl salicylate 18.24%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.

    When using this product

    Do not apply to wounds or damaged skin

    Do not bandage tightly

    Avoid contact with eyes

    Do not use with a heating pad

    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 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 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 between 20-25°C (68-77°F). Tamper Evident: Do not use it seal under cap is broken or missing

  • Inactive ingredients

    Allantoin, benzoic acid, cetearyl alcohol, cetearyl glucoside, pheonoxyethanol, stearic acid, water.

  • Questions?

    Call toll free +506 (800)-937-6572 laboratorioszepol@zepolab.com

  • zpol ULTRA 1.02 Oz

    NDC 55715-008-01

    zpol ULTRA

    Topical analgesic cream

    1.02 Oz

    ZepoLAB

    Zpol 1.02 Oz

  • zpol ULTRA 2.08 Oz

    NDC 55715-008-02

    zpol ULTRA

    Topical analgesic cream

    2.08 Oz

    ZepoLAB

    Zpol 2.08 Oz

  • Zpol ULTRA 4.02 Oz

    NDC 55715-008-03

    zpol ULTRA

    Topical analgesic cream

    4.02 Oz

    ZepoLAB

    Zpol 4.02 Oz

  • INGREDIENTS AND APPEARANCE
    ZPOL ULTRA 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55715-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.84 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE18.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55715-008-0129 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/04/2024
    2NDC:55715-008-0259 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/04/2024
    3NDC:55715-008-03119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/04/2024
    Labeler - Laboratorios Zepol S.A. (853070985)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Zepol S.A.853070985manufacture(55715-008)
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