Label: REAL TIME PAIN RELIEF MAXX TOPICAL ANALGESIC- menthol 1.5% 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 February 10, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 1.5%

  • Purpose

    Topical analgesic

  • 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
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use 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.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children over 2 years:

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

    children 2 years or younger: ask a doctor

  • Inactive ingredients

    Aloe Barbadensis Leaf, Anthemis nobilis, Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis, Caprylyl Glycol, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum, Matricaria chamomilla, Mentha Piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia cordata, Triethanolamine.

  • SPL UNCLASSIFIED SECTION

    Distributed by: RTPR LLC, Edmond, OK 73012

  • PRINCIPAL DISPLAY PANEL - 120 mL Label

    4ozbottle

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF MAXX  TOPICAL ANALGESIC
    menthol 1.5% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPSICUM (UNII: 00UK7646FG)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (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)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    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)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-100-3397.5 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2015
    2NDC:58133-100-04120 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2014
    3NDC:58133-100-1545 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2014
    4NDC:58133-100-12473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2014
    5NDC:58133-100-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2014
    6NDC:58133-100-60120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/10/2020
    7NDC:58133-100-62354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2014
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Registrant - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-100)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!