TRILOGEL- lidocaine hydrochloride gel

Trilogel by

Drug Labeling and Warnings

Trilogel by is a Otc medication manufactured, distributed, or labeled by Trifluent Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine HCl, USP 2.8%

Purpose

Topical analgesic

Uses

For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

Warnings

For external use only

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes

Stop use and ask a physician if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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 physician.

Other Information

Store at 20-25°C (68-77°F). Protect from freezing.

Inactive Ingredients

Caprylyl Glycol, Carica Papaya (Papaya) Fruit Extract, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcellulose, Phenoxyethanol, Purified Water, Sodium Lactate, Xanthan Gum.

Questions or Comments?

(210) 944-6920

PRINCIPAL DISPLAY PANEL - 57 G Pouch Label

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

NDC: 73352-620-01

TRIFLUENT
PHARMA™

Trilogel™

Lidocaine HCl 2.8%

Topical Analgesic Gel

For the temporary relief of pain associated with minor burns, sunburn,
minor cuts, scrapes, insect bites, and minor skin irritations.

NET WT. 2 OZ. (57 G)

INGREDIENTS AND APPEARANCE

TRILOGEL 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73352-620
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	28 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
PAPAYA (UNII: KU94FIY6JB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM LACTATE (UNII: TU7HW0W0QT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73352-620-01	1 in 1 POUCH	06/24/2024
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M017	06/24/2024

Labeler - Trifluent Pharma LLC (117167281)