Otc - Active Ingredient
Camphor 3.5%, Menthol 3.5%
The following Structured Product Label (SPL) was submitted to the FDA by Tommie Copper, Inc. for the product Pain Relief Liquid Roller (NDC 72562-167). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Camphor 3.5%, Menthol 3.5%
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--Do not use while smoking or near heat or flame. When using this product avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. 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 to the affected area not more than 3 to 4 times daily.
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Extract, Aminomethyl Propanol, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia (Coneflower) Extract, Ethyhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, FD&C Blue No 1, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Isopropyl Alcohol, Juniperus Communis (Juniper) Fruit Extract, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Water.
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