Label: REAL TIME PAIN RELIEF FOOT CREAM TOPICAL ANALGESIC- menthol 1.5% cream

  • Category: HUMAN OTC DRUG LABEL

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 January 3, 2018

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  • ACTIVE INGREDIENT

    Menthol 1.5%

  • PURPOSE

    Topical analgesic

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center right away.

  • USES

    Temporarily relieves minor pain associated with

    • arthritis
    • muscle strains
    • sprains
    • bruises
    • cramps
  • WARNINGS

    for external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with heating pad
    • avoid contact with eyes or mucus membranes
    • do not apply to wounds or damaged skin

    Stop using and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • irritation develops

    If pregnant or breast-feeding

    ask a health professional before use

  • DIRECTIONS

    adults and children over 2 years

    • apply generously to affected area
    • massage into painful area until throughly absorbed into skin
    • repeat as necessary, but no more than 4 times daily

    Children 2 years or younger:ask a doctor

  • INACTIVE INGREDIENTS

    Allantoin, Aloe barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Ascorbic Acid, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Eucalyptus globulus Leaf Oil, Hydrogenated Vegetable Oil, Hypericum perforatum (St. John’s Wort), Lactic Acid, Lanolin, Matricaria chamomilla (Chamomile), Melaleuca alternifolia (Tea Tree) Leaf Oil, Paraffin, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Purified Water, Retinyl Palmitate, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sodium Borate, Sorbitan Sesquioleate, Stearyl Alcohol, Tilia sylvestris (Lime Tree), Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL and DRUG FACTS

    labeling

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF FOOT CREAM  TOPICAL ANALGESIC
    menthol 1.5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-900
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
    ALPHA-TOCOPHERYLOXYACETIC ACID (UNII: JW7FJR3ZLY)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EMU OIL (UNII: 344821WD61)  
    WATER (UNII: 059QF0KO0R)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    RETINYL PROPIONATE (UNII: 32JK994WMC)  
    .ALPHA.-ISOBUTYLPHENETHYL ALCOHOL (UNII: 2SBL0E1I0N)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-900-04125 g in 1 JAR; Type 0: Not a Combination Product01/31/2014
    2NDC:58133-900-1440 g in 1 JAR; Type 0: Not a Combination Product01/31/2014
    3NDC:58133-900-08227 g in 1 JAR; Type 0: Not a Combination Product01/31/2014
    4NDC:58133-900-16453 g in 1 JAR; Type 0: Not a Combination Product01/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/30/2013
    Labeler - Cosmetic Specialty labs, Inc. (032973000)
    Registrant - Cosmetic Specialty labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty labs, Inc.032973000manufacture(58133-900)
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