Trolamine salicylate is an external analgesic and a chemical sunscreen agent. In 1983, the FDA classified trolamine salicylate as having unproven effectiveness and safety as an external analgesic. One randomized double-blind crossover study of 25 patients with symptomatic osteoarthritis of the knee reported that trolamine salicylate 10% cream was no more effective than placebo. However, in 1994, one manufacturer asked the FDA to reinvestigate trolamine salicylate based on data from unpublished studies which report trolamine salicylate to be effective in relieving the stiffness and pain associated with arthritis. Further investigation is needed into the efficacy of trolamine salicylate as a topical analgesic. Trolamine salicylate is also used in sunscreen products as a UVB sunblock (see Sunscreens monograph).
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
Cream/Ointment/Lotion Formulations
-Apply generously to the affected area.
-Massage lightly into painful area until thoroughly absorbed into the skin.
-Repeat as necessary, but no more than four times daily.
-Do not bandage tightly.
-Do not use with a heating pad or other heating device.
-Do not apply to wounds or damaged skin.
Possible adverse reactions of trolamine salicylate include allergic contact dermatitis, folliculitis, photoallergic contact dermatitis, skin irritation, or skin rash.
Do not use trolamine salicylate on broken, inflamed or irritated skin. Do not bandage tightly after application. Do not use heating pads or other heating devices.
Because trolamine salicylate is contained in some sunscreens, patch testing is recommended. This is recommended in patients with photodermatoses in order to avoid sunscreen-induced allergic reactions.
Do not use trolamine salicylate in patients with salicylate hypersensitivity. Do not use trolamine salicylate if you are allergic to salicylates (including aspirin) or have a know or suspected hypersensitivity to any ingredient in this product.
Trolamine salicylate is not for ophthalmic administration. Avoid contact with eyes and mucous membranes.
Trolamine salicylate is not indicated neonates and infants and children.
There are no adequate and well-controlled studies of trolamine salicylate in pregnancy. Thus, it is not known whether this drug will cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to a pregnant woman with caution and only if clearly needed.
It is not know whether trolamine salicylate is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For the topical treatment of mild pain including musculoskeletal pain and/or joint pain:
Trolamine salicylate should not be used for self-medication of pain for longer than 10 days, unless directed by a physician.
Topical dosage (Mobisyl):
Adults and Adolescents: Apply cream or lotion liberally and gently rub into the cleansed affected area 2 to 4 times per day, preferably with one application at bedtime.
Neonates, Infants and Children: Safety and efficacy have not been established.
Topical dosage (Aspercreme):
Adults, Adolescents and Children > = 10 years: Apply to the affected area no more than three to four times daily.
Neonates, Infants and Children < 10 years: Safety and efficacy have not been established.
Topical dosage (Myoflex):
Adults, Adolescents and Children > = 2 years: Apply cream or lotion liberally and gently rub into the cleansed affected area not more than 3 to 4 times per day. Affected areas may be wrapped loosely with an elastic bandage.
Neonates, Infants and Children < 2 years: Safety and efficacy have not been established.
Maximum Dosage Limits:
-Adults
4 applications/day.
-Geriatric
4 applications/day.
-Adolescents
4 applications/day.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Trolamine Salicylate products.
Trolamine salicylate is an external analgesic and a chemical sunscreen agent. It is often used in topical rubefacient preparations in concentrations between 10-20% and is thought to exert its action through a counter-irritant effect. In sunscreens, trolamine salicylate is a chemical blocker that only provides protection against UVB radiation.
Trolamine salicylate is administered topically. Information on metabolism and excretion of trolamine salicylate is unknown.
-Route-Specific Pharmacokinetics
Topical Route
Trolamine salicylate is rapidly and well-absorbed following topical administration. Information on the distribution of trolamine salicylate is unknown.