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Real Time Pain Relief (Cosmetic Specialty labs, Inc.)

Available Formats

Dosage Form Package Information Links
LOTION 59 mL in 1 TUBE (58133-052-02) Label Information
LOTION 89 mL in 1 BOTTLE (58133-052-03) Label Information
LOTION 473 mL in 1 BOTTLE (58133-052-16) Label Information
LOTION 148 mL in 1 TUBE (58133-052-05) Label Information

Complete Real Time Pain Relief Information

  • ACTIVE INGREDIENT

    Menthol 1%


  • 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
    • 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 deveops

    If pregnant or breast-feeding

    ask a health professional before use


  • DIRECTIONS

    adults and children over 12 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 12 years or younger

    ask a doctor


  • INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf, Anthemis nobilis Extract, Arnica Montana Flower Extract, Blue 1, Calendula officinalis Extract, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus Extract, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Fragrance, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Methylparaben, Methysulfonylmethane, Pimpinella Anisum (Anise) Fruit Extract, Propylparaben, Purified Water, Ruta Graveolens (Rue) Leaf/Root/Stem Extract. Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol. Tilia sylvestris Extract, Triethanolamine.


  • PRINCIPAL DISPLAY PANEL

    Display Panel

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF  TOPICAL ANALGESIC
    menthol 1% lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-052
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) menthol 1 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPSICUM (UNII: 00UK7646FG)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EMU OIL (UNII: 344821WD61)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ANISE (UNII: 21C2F5E8RE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    RUTA GRAVEOLENS FLOWERING TOP OIL (UNII: VDI0O08XRA)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    SORBITOL (UNII: 506T60A25R)  
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58133-052-02 59 mL in 1 TUBE
    2 NDC:58133-052-03 89 mL in 1 BOTTLE
    3 NDC:58133-052-05 148 mL in 1 TUBE
    4 NDC:58133-052-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/30/2013
    Labeler - Cosmetic Specialty labs, Inc. (032973000)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmetic Specialty labs, Inc. 032973000 manufacture(58133-052)