TOMMIE COPPER PAIN RELIEF- menthol 16% spray 
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 Liquid Spray

Menthol 16%


Topical Analgesic

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

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . 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.

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Alcohol Denat., Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Propylene Glycol, Water

Label

TOMMIE COPPER PAIN RELIEF 
menthol 16% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72562-910
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CALENDULA ARVENSIS LEAF (UNII: 3U3U118F2L)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
JUNIPER BERRY (UNII: O84B5194RL)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72562-910-04113 g in 1 CAN; Type 0: Not a Combination Product11/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/30/2020
Labeler - Tommie Copper, Inc. (081176569)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72562-910)

Revised: 1/2023
Document Id: f201fcdb-2c05-5618-e053-2a95a90aee2a
Set id: b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8
Version: 2
Effective Time: 20230111
 
Tommie Copper, Inc.