TOMMIE COPPER PAIN RELIEF MAXIMUM STRENGTH- 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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Pain Relief Cream, Trolamine Salicylate 10%

Trolamine Salicylate 10%

Topical Analgesic.

For the temporary relief of minor aches and pain associated with simple backache, 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, avoid taking a bath or shower within 1 hour before or after applying, do not bandage or use with a heating pad, avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin.

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

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

Keep out of reach of children.

Adults and children 12 years of age: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

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, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

Label

TOMMIE COPPER PAIN RELIEF  MAXIMUM STRENGTH
trolamine salicylate 10% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72562-103
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
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
JUNIPER BERRY (UNII: O84B5194RL)  
CHAMOMILE (UNII: FGL3685T2X)  
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72562-103-0385 g in 1 TUBE; Type 0: Not a Combination Product12/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/14/2020
Labeler - Tommie Copper, Inc. (081176569)

Revised: 12/2020
Document Id: b622c14f-9bf2-0bbd-e053-2a95a90a2adc
Set id: b622c14f-9bf3-0bbd-e053-2a95a90a2adc
Version: 1
Effective Time: 20201210
 
Tommie Copper, Inc.