Drug Facts

Active ingredients	Purpose
Menthol 2%	Topical Analgesic
Methyl Salicylate 10%	Topical Analgesic

Uses

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

Warnings

For external use only

Do not use

Do not use otherwise than as directed.

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

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

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.

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

Directions

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

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

Inactive ingredients

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?

(210) 944-6920

PRINCIPAL DISPLAY PANEL - 85 G Pouch Tube Label

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

TRICYLATE
menthol, unspecified form and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73352-575
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	20 mg in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PAPAYA (UNII: KU94FIY6JB)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73352-575-04	1 in 1 POUCH	06/17/2024
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M017	06/17/2024

Labeler - Trifluent Pharma LLC (117167281)

TRICYLATE™