Label: COPPERLIFE 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 January 9, 2023

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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, Anthemis Nobilis (Roman Chamomile) Flower Oil, Arnica Montana (Arnica) Flower Extract, Boswellia Serrata (Frankincense) Extract, Cannabis Sativa (Hemp) Extract, Capsicum Annuum (Paprika) Extract, Cetyl Alcohol, Citrus Limon (Lemon) Peel Oil, Curcuma Longa (Tumeric) Root Extract, Glycerin, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Salix Alba (Willow) Bark Extract, Stearic Acid, Triethanolamine, Trifolium Pratense (Clover) Flower Extract, Water, Zingiber Officinale (Ginger) Root Extract.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    COPPERLIFE PAIN RELIEF 
    trolamine salicylate 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72562-123
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    GINGER (UNII: C5529G5JPQ)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CANNABIS SATIVA SEED (UNII: QE567Z26NG)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    PAPRIKA (UNII: X72Z47861V)  
    LEMON OIL (UNII: I9GRO824LL)  
    TURMERIC (UNII: 856YO1Z64F)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72562-123-2570 g in 1 TUBE; Type 0: Not a Combination Product08/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/11/2021
    Labeler - Tommie Copper, Inc. (081176569)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72562-123)