TOMMIE COPPER PAIN RELIEF MAXIMUM STRENGTH- trolamine salicylate 10% cream

Tommie Copper Pain Relief by

Drug Labeling and Warnings

Tommie Copper Pain Relief by is a Otc medication manufactured, distributed, or labeled by Tommie Copper, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Trolamine Salicylate 10%

PURPOSE

Topical Analgesic.

DOSAGE & ADMINISTRATION

For the temporary relief of minor aches and pain associated with simple backache, 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, 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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

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.

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, 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOMMIE COPPER PAIN RELIEF  MAXIMUM STRENGTH
trolamine salicylate 10% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72562-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72562-103-03	85 g in 1 TUBE; Type 0: Not a Combination Product	12/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/14/2020

Labeler - Tommie Copper, Inc. (081176569)