FDA.reportPublic FDA data

Tricylate

Manufacturer
Trifluent Pharma LLC
Effective date
2025-10-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:38:56

Label at a glance#

ProductTricylate
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use; consult a doctor.

Storage and handling

Store at temperatures less than 30°C (86°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Menthol 2%Topical Analgesic
Methyl Salicylate 10%Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • Do not use otherwise than as directed.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Do not use; consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at temperatures less than 30°C (86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alkyl (C12-15) benzoate, butylparaben, Carica papaya (papaya) fruit extract, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, dimethicone, disodium EDTA, emulsifying wax, ethylparaben, glycerin, glycerol stearate, hydrogenated polydecene, hydroxyethyl cellulose, isobutylparaben, methylparaben, PEG 100 stearate, phenoxyethanol, propylene glycol, propylparaben, purified water, sodium lactate, sodium polyacrylate, trideceth-6, xanthan gum.

Questions/Comments?

OTC - QUESTIONS SECTION

(210) 944-6920

PRINCIPAL DISPLAY PANEL - 85 G Pouch Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tear at notch to open. Do not use if seal is broken.

NDC 73352-575-04

TRIFLUENT
PHARMA™

Tricylate™

2% Menthol
10% Methyl Salicylate

Topical Analgesic Cream

NET WT. 3 OZ. (85 G)

PRINCIPAL DISPLAY PANEL - 85 G Pouch Tube Label
PRINCIPAL DISPLAY PANEL - 85 G Pouch Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311503menthol 2 % / methyl salicylate 10 % Topical CreamPSN5
2685260Tricylate 2 % / 10 % Topical CreamPSN5
2685260menthol 20 MG/ML / methyl salicylate 100 MG/ML Topical Cream [Tricylate]SBD5
311503menthol 20 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD5
311503menthol 2 % / methyl salicylate 10 % Topical CreamSY5
2685260Tricylate (menthol 2 % / methyl salicylate 10 % ) Topical CreamSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-575-04Tricylate85 g in 1 TUBECREAM855
73352-575-04Tricylate1 in 1 POUCHCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-575-04GM - Gram73352-575ac3e2d75-a159-4366-b14f-61a3a0a9050512024-09-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73352-57573352-575-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLPARABEN3QPI1U3FV8IACT
PAPAYAKU94FIY6JBIACT
SAFFLOWER OIL65UEH262ISIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
HYDROGENATED POLYDECENE TYPE IU333RI6EB7IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
ISOBUTYLPARABEN0QQJ25X58GIACT
METHYLPARABENA2I8C7HI9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM LACTATETU7HW0W0QTIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TRIDECETH-63T5PCR2H0CIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-06-11full-release2026-06-01 00:13:44

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
ndc (package): 73352-575-04
ndc (product): 73352-575
ndc11 (package): 73352057504
spl id: 74585171-4174-47d4-a09c-7f50634f1f83
spl set id: 4869b63a-e01e-4a79-a493-7a1b4d3e914b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.