Drug Facts
Active Ingredient, Purpose
Methyl Salicylate 12.5%, Topical Analgesic/Anti-Inflammatory
Menthol USP 4%, Topical Analgesic
Camphor 0.2%, Topical Analgesic, Anti-Inflammatory
Reed Therapeutics Pain Relieving Therapy
FDA Label NDC 76437-609
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reed Therapeutics for the product Reed Therapeutics Pain Relieving Therapy (NDC 76437-609). 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 drug facts, uses, warnings, keep out of reach of children, when using this product, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporary relief of minor aches and pain of sore muscles and joints associated with: arthritis, backache, bursitis, muscle cramps, muscle strain and sprains, plantar fasciitis, tendonitis
Warnings
For external use only. Keep away from excessive heat or open flame.
If pregnant or breast-feeding: Ask healthcare professional before use.
Keep Out Of Reach Of Children
If accidently ingested, seek medical help or contact Poison Control Center immediately.
When Using This Product
When using this product:
Avoid contact with eyes or mucous membranes
Do not apply to wounds or damaged skin
Do not bandage
Do not use with heating pad or device
Do not use with other ointments, cream, sprays, or liniments
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
Condition worsens or if symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days
Excessive skin irritation occurs
Directions
Adults and children 12 year and older: Gently massage and apply to affected area 3-4 times daily. Massage not necesssary but may enhance relief.
Children under 12 years of age: consult a physician.
Other Information
Store at controlled room temperture 68' to 77' F. Close cap after use.
Inactive Ingredients
Carbomer 940, DMDM Hydantoin, FD&C Blue #1, Paragurariensis Extract, Methylparaben, Propylparaben, Tea Tree oil, Thyme oil, Triethanolamine, Water(D.I), FD&C Yellow #5
Package Label.Principal Display Panel
Label Of Rollon (Rollon)
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