ZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]

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ZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]
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NDC 55715-001-01, 55715-001-90
Set ID ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9
Category HUMAN OTC DRUG LABEL
Packager Laboratorios Zepol S.A.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredients


    Camphor 6.55%
    Menthol 6.55%

    Purpose

    Topical Analgesic

  • Uses

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

  • Warnings

    For external use only.
    Avoid contact with eyes.
    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

    Do not apply

    to wounds or damaged skin.
    Do not bandage tightly.

    Keep out of reach of children.

    If swallowed, get medical help or contact 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: Consult a physician.

  • Other information

    Store at 30 degrees C (86 degrees F).

  • Inactive Ingredients

    Eucalyptol, Petrolatum, Thyme Oil, Turpentine Oil Rectified.

  • PRINCIPAL DISPLAY PANEL

    Zepol Topical Analgesic 1 oz

  • PRINCIPAL DISPLAY PANEL

    Zepol Topical Analgesic Outer Box

  • Package Labeling:

    Outer PackageInner Package

  • Package Labeling:

    Outer Package2Inner Package2

  • Zepol Topical Analgesic Ointment,12 units (0.35oz/10g) (55715-001-12)

    LabelLabel1Label2

  • INGREDIENTS AND APPEARANCE
    ZEPOL TOPICAL ANALGESIC 
    camphor, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55715-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6.55 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6.55 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTOL (UNII: RV6J6604TK)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    THYME OIL (UNII: 2UK410MY6B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55715-001-0130 g in 1 TUBE; Type 0: Not a Combination Product10/05/2009
    2NDC:55715-001-901 in 1 BOX10/05/2009
    290 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:55715-001-1212 in 1 BOX10/01/2019
    310 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/05/2009
    Labeler - Laboratorios Zepol S.A. (853070985)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Zepol S.A853070985manufacture(55715-001)
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