Label: TOMMIE COPPER PAIN RELIEF MAXIMUM STRENGTH- trolamine salicylate 10% cream
- NDC Code(s): 72562-103-03
- Packager: Tommie Copper, Inc.
- Category: HUMAN OTC DRUG LABEL
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 11, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
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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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
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INGREDIENTS AND APPEARANCE
TOMMIE COPPER PAIN RELIEF MAXIMUM STRENGTH
trolamine salicylate 10% creamProduct 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)