Label: TOMMIE COPPER PAIN RELIEF- trolamine salicylate 10% 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 August 20, 2021

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  • ACTIVE INGREDIENT

    Trolamine Salicylate 10%

  • PURPOSE


    Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

  • 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 Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask a health professional.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat if necessary but not more than 4 times daily. Children under 12 years of age: ask a doctor.

  • INACTIVE INGREDIENT

    Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Mentha Piperita (Peppermint) Oil, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    TOMMIE COPPER PAIN RELIEF 
    trolamine salicylate 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72562-223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CUCUMBER (UNII: YY7C30VXJT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72562-223-2570 g in 1 TUBE; Type 0: Not a Combination Product08/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/19/2021
    Labeler - Tommie Copper, Inc. (081176569)
    Registrant - Derma Care Research Labs, LLC (116817470)