Overview
Trolamine salicylate is an organic compound or a salt formed between triethanolamine and salicylic acid. Triethanolamine neutralizes the acidity of the salicylic acid. It is a topical analgesic used for temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises. Unlike other topical analgesics, trolamine salicylate has no distinct odor which improves patient acceptability . It also displays low systemic absorption upon dermal or topical administration and has low skin irritant properties . As with other salicylates, trolamine salicylate is an inhibitor of cyclo-oxygenase (COX) enzymes with no reported selectivity towards a specific enzyme isoform. Trolamine salicylate serves as an active ingredient in topical over-the-counter products for temporary management of mild to moderate muscular and joint pains.
Indication
Indicated for the temporary relief of aches, and pains of muscles and joints associated with backache, lumbago, strains, bruises, sprains and arthritic or rheumatic pain, pain of tendons and ligaments .
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/11/03 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Home Aide Diagnostics, Inc. | 69379-010 | TOPICAL | 10 g in 100 g | 3/9/2015 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GOANNA ARTHRITIS CREAM trolamine salicylate 100mg/g tube (reformulation) | 78992 | Medicine | A | 6/14/2001 | |
| DOUBLE D ARTHRITIS RUB 100mg/g cream | 51153 | Milpharma Pty Ltd | Medicine | A | 12/14/1994 |
| DENCORUB ARTHRITIS CREAM trolamine salicylate 100mg/g cream tube | 10148 | Medicine | A | 6/13/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ARTHUR ITIS CREAM | nabtech pharma inc. | 02231231 | Cream - Topical | 10 % | 9/2/1997 |
| MYOFLEX ULTRA STRENGTH | bayer inc consumer care | 02226014 | Cream - Topical | 20 % | 3/5/1997 |
| MYOFLEX EXTRA STRENGTH | exzell pharma inc | 02226022 | Cream - Topical | 15 % / W/W | 12/30/1989 |
| MUSCLE & JOINT NO ODOUR REGULAR STRENGTH | church & dwight canada corp | 02473143 | Cream - Topical | 13.3 % | 8/31/2018 |
| ARTHRITIS EXTRA STRENGTH ROLL-ON LOTION | church & dwight canada corp | 02315548 | Lotion - Topical | 10 % / W/W | 9/15/2008 |
| ASPERCREME CREME RUB 10% | sanofi consumer health inc | 02074710 | Cream - Topical | 10 % / W/W | 12/31/1980 |
| MYOFLEX REGULAR STRENGTH | exzell pharma inc | 02152827 | Cream - Topical | 10 % / W/W | 12/31/1996 |
| MYOFLEX ICE COLD PLUS - GEL | bayer inc consumer care | 02153076 | Gel - Topical | 15 % | 9/10/1996 |
| MYOFLEX DEEP THERAPY | bayer inc consumer care | 02278510 | Patch - Topical | 12.5 % | 2/9/2007 |
| FLEXACREME | prodemdis enr. | 02240528 | Cream - Topical | 10 % | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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