Label: TRU-MICIN- trolamine 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 June 5, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Trolamine salicylate 10%

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief of pain associated with:

    • Joint and Muscle Inflammation
    • Nerve damage
    • Fitness and Sports Injuries
  • Warnings

    For external use only.

    Allergy alert

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using this product

    use only as directed

    • do not bandage tightly or use with a heating pad
    • avoid contact with the eyes or mucous membranes
    • do not apply to wounds or damaged skin

    Stop use and ask a doctor if

    symptoms persist for more than 7 days or clear up and occur again within a few days

    • redness is present
    • irritation develops
    • condition worsens

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

    Keep out of reach of children. If swallowed, seek immediate medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    Adults and children over 12 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed
    • repeat if necessary, but not more than 4 times daily
  • Other Information

    Store at 20-25°C (68-77°F)

  • Inactive Ingredients

    Alpha-lipoic acid, Caprylyl Glycol, Cetylalcohol, Coco Caprylate/Caprate, Curcuma longa, Dimethicone, DMDM Hydantoin, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Ocimum sanc, Octyl Methoxycinnamate, Olibanum, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Rosmarinus, Salix Alba, Stearic Acid, Stearyl Stearate, Tocopheryl Acetate (Vitamin-E), Water, Zingiber

  • Questions?

    Call 877-669-4227

  • PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

    Odorless • Non-greasy
    Fast-acting

    Tru-micin®

    Topical Analgesic

    Temporary relief of pain
    associated with
    joint, muscle inflammation
    and nerve damage

    3.5 fl. oz (100 ml)

    NDC 51230-418-01

    Principal Display Panel - 100 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    TRU-MICIN 
    trolamine lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51230-418
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Trolamine (UNII: 9O3K93S3TK) (Trolamine - UNII:9O3K93S3TK) Trolamine0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Coco-Caprylate (UNII: 4828G836N6)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Octinoxate (UNII: 4Y5P7MUD51)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearyl Stearate (UNII: 5WX2EGD0DK)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Petrolatum (UNII: 4T6H12BN9U)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Water (UNII: 059QF0KO0R)  
    Turmeric (UNII: 856YO1Z64F)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    .Alpha.-Lipoic Acid (UNII: 73Y7P0K73Y)  
    Salix Alba Bark (UNII: 205MXS71H7)  
    Ocimum Tenuiflorum Top (UNII: 34T63W8ULS)  
    Ginger (UNII: C5529G5JPQ)  
    Rosemary (UNII: IJ67X351P9)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51230-418-01100 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/07/2013
    Labeler - Truceuticals, LLC (963324954)
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