Label: REAL TIME PAIN RELIEF SPORTS CREAM TOPICAL ANALGESIC- menthol 0.5% lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 2, 2018

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  • ACTIVE INGREDIENT

    Menthol 0.5%

  • 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
    • simple backache
    • muscle strains
    • sprains
    • bruises
  • WARNINGS

    for external use only

    When using this product

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

    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

    children 12 years or younger

    ask a doctor

  • INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria Chamomilla), Coriandrum Sativum (Coriander) Fruit Oil, Curcuma Longa (Turmeric) Extract, Cupressus sempervirens (Cypress) Fruit Extract, Emu Oil, Fragrance, Gaultheria procumbens (Wintergreen) Oil, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Helichrysum Italicum Flower, Hypericum perforatum (St. John’s Wort), Jasminum Officianale (Jasmine) Flower Extract, Lavendula Angustifolia (Lavender) Oil, Magnesium Chloride, Methylsulfonylmethane, Myristica Fragrans (Nutmeg) Extract, Origanum Majorana (Marjoram) Leaf Extract, Phenoxyethanol, Purified Water, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF SPORTS CREAM  TOPICAL ANALGESIC
    menthol 0.5% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    EMU OIL (UNII: 344821WD61)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    WATER (UNII: 059QF0KO0R)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    SORBITOL (UNII: 506T60A25R)  
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
    MYRISTICA FRAGRANS WHOLE (UNII: MF7T8BM40A)  
    TETRASODIUM DIETHYLENETRIAMINEPENTAMETHYLENEPHOSPHONATE (UNII: E6DVO371LC)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    2-(DIPROPYLAMINO)ETHANOL (UNII: 0916206V9S)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ORIGANUM MAJORANA (UNII: R40XM3HU5X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK)  
    CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-700-04120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/31/2014
    2NDC:58133-700-12345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/31/2014
    3NDC:58133-700-40120 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2014
    4NDC:58133-700-1545 mL in 1 TUBE; 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(58133-700)
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