Trolamine Salicylate

Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief:  Kiran Singh, M.D. [2]

## Disclaimer

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## Overview

Trolamine Salicylate is an analgesic that is FDA approved for the treatment of musculoskeletal pain and osteoarthritis. Common adverse reactions include erythema, skin irritation.

## Adult Indications and Dosage

### FDA-Labeled Indications and Dosage (Adult)

## Indications

* Temporarily relieves minor pain associated with:

* Arthritis
* Simple backache
* Muscle strains
* Sprains
* Bruises

### Off-Label Use and Dosage (Adult)

#### Guideline-Supported Use

* There is limited information regarding Off-Label Guideline-Supported Use of Trolamine Salicylate in adult patients.

#### Non–Guideline-Supported Use

* There is limited information regarding Off-Label Non–Guideline-Supported Use of Trolamine Salicylate in adult patients.

## Pediatric Indications and Dosage

### FDA-Labeled Indications and Dosage (Pediatric)

* There is limited information regarding FDA-Labeled Use of Trolamine Salicylate in pediatric patients.

### Off-Label Use and Dosage (Pediatric)

#### Guideline-Supported Use

* There is limited information regarding Off-Label Guideline-Supported Use of Trolamine Salicylate in pediatric patients.

#### Non–Guideline-Supported Use

* There is limited information regarding Off-Label Non–Guideline-Supported Use of Trolamine Salicylate in pediatric patients.

## Contraindications

There is limited information regarding Trolamine Salicylate Contraindications in the drug label.

## 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
* Do not bandage tightly or use with a heating pad
* Avoid contact with the eyes or mucous membranes
* Do not apply to wounds or damaged skin

Stop use and ask a doctor if

* Condition worsens
* Symptoms persist for more than 7 days or clear up and occur again within a few days

* Redness is present

* Irritation develops

If pregnant or breast-feeding

* Ask a health professional before use.

Keep out of reach of children.

* If swallowed, get medical help or contact a Poison Control Center right away.

## Adverse Reactions

### Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Trolamine Salicylate in the drug label.

### Postmarketing Experience

There is limited information regarding Postmarketing Experience of Trolamine Salicylate in the drug label.

## Drug Interactions

There is limited information regarding Trolamine Salicylate Drug Interactions in the drug label.

## Use in Specific Populations

#### Pregnancy

Pregnancy Category (FDA):  There is no FDA guidance on usage of Trolamine Salicylate in women who are pregnant.
Pregnancy Category (AUS):

* Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trolamine Salicylate in women who are pregnant.

#### Labor and Delivery

There is no FDA guidance on use of Trolamine Salicylate during labor and delivery.

#### Nursing Mothers

There is no FDA guidance on the use of Trolamine Salicylate with respect to nursing mothers.

#### Pediatric Use

There is no FDA guidance on the use of Trolamine Salicylate with respect to pediatric patients.

#### Geriatic Use

There is no FDA guidance on the use of Trolamine Salicylate with respect to geriatric patients.

#### Gender

There is no FDA guidance on the use of Trolamine Salicylate with respect to specific gender populations.

#### Race

There is no FDA guidance on the use of Trolamine Salicylate with respect to specific racial populations.

#### Renal Impairment

There is no FDA guidance on the use of Trolamine Salicylate in patients with renal impairment.

#### Hepatic Impairment

There is no FDA guidance on the use of Trolamine Salicylate in patients with hepatic impairment.

#### Females of Reproductive Potential and Males

There is no FDA guidance on the use of Trolamine Salicylate in women of reproductive potentials and males.

#### Immunocompromised Patients

There is no FDA guidance one the use of Trolamine Salicylate in patients who are immunocompromised.

## Administration and Monitoring

#### Administration

* Topical

Adults and children over 12 years:

* Apply generously to affected area

* Massage into painful area until thoroughly absorbed into skin

* Repeat as necessary, but not more than 4 times daily

#### Monitoring

There is limited information regarding Monitoring of Trolamine Salicylate in the drug label

## IV Compatibility

There is limited information regarding IV Compatibility of Trolamine Salicylate in the drug label.

## Overdosage

There is limited information regarding Chronic Overdose of Trolamine Salicylate in the drug label.

## Pharmacology

This image is provided by the National Library of Medicine.

### Mechanism of Action

There is limited information regarding Mechanism of Action of Trolamine Salicylate in the drug label.

### Structure

There is limited information regarding Structure of Trolamine Salicylate in the drug label.

### Pharmacodynamics

There is limited information regarding Pharmacodynamics of Trolamine Salicylate in the drug label.

### Pharmacokinetics

There is limited information regarding Pharmacokinetics of Trolamine Salicylate in the drug label.

### Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Trolamine Salicylate in the drug label.

## Clinical Studies

There is limited information regarding Clinical Studies of Trolamine Salicylate in the drug label.

## How Supplied

There is limited information regarding Trolamine Salicylate How Supplied in the drug label.

### Storage

There is limited information regarding Trolamine Salicylate Storage in the drug label.

## Images

### Drug Images

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This pill image is provided by the National Library of Medicine's PillBox.

### Package and Label Display Panel

This image is provided by the National Library of Medicine. This image is provided by the National Library of Medicine. File:Trolamine Salicylate11.png

This image of the FDA label is provided by the National Library of Medicine.

## Patient Counseling Information

There is limited information regarding Patient Counseling Information of Trolamine Salicylate in the drug label.

## Precautions with Alcohol

* Alcohol-Trolamine Salicylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

## Brand Names

* TROLAMINE SALICYLATE®[1]

## Look-Alike Drug Names

* A® — B®[2]

## Drug Shortage Status

## Price

## References

The contents of this FDA label are provided by the National Library of Medicine.

1. ↑ "trolamine salicylate cream".
2. ↑ "http://www.ismp.org". External link in `|title=` (help)