COPPERLIFE PAIN RELIEF- trolamine salicylate 10% cream 
Tommie Copper, Inc.

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.

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TC Pain Relief Cream (Copperlife)

Trolamine Salicylate 10%


Topical Analgesic

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

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.

If pregnant or breast-feeding ask a health professional.

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

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.

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.

Label

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)

Revised: 1/2023
Document Id: f1db8929-9b99-0d6e-e053-2995a90a817f
Set id: c94d00f9-42ce-1d43-e053-2a95a90a058d
Version: 3
Effective Time: 20230109
 
Tommie Copper, Inc.