Label: TRURELIEF RUBITON RUB IT WHERE IT HURTS- menthol cream

  • 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 8, 2022

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

  • Active Incredient

    Menthol, 3.0%

  • 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

    When using this prodcutuse only as directed do not bandage tightly or use with heating pad avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin

  • STOP USE

    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

  • KEEP OUT OF REACH OF CHILDREN

    If pregnant or breast-feeding, ask a health professional before use.

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

  • Directions:

    Adults and children over 12 years: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 4 time daily

    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 officinalis (Marigold), Caprylyl Glycol, Capsicum frutescens Fruit, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Chamomilla recutita (Matricaria Chamomilla), Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Fragrance, Hamamelis virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum (St. John's Wort), Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.

  • Package Label

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    TRURELIEF RUBITON RUB IT WHERE IT HURTS 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-451
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPSICUM (UNII: 00UK7646FG)  
    EMU OIL (UNII: 344821WD61)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-451-0488 mL in 1 TUBE; Type 0: Not a Combination Product02/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/08/2022
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-451) , pack(58133-451) , label(58133-451) , analysis(58133-451)