Lidocaine HCI by Trifluent Pharma, LLC LIDOCAINE HCI cream

Lidocaine HCI by

Drug Labeling and Warnings

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

Drug Details [pdf]

Lidocaine HCI 4% Cream - Topcial Analgesic Pain Relieving Cream

Active Ingredient

Lidocaine HCI 4%...................................Topical analgesic

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac.

Warnings

• For external use only

• Avoid contact with eyes

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

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, discontinue use or this product and consult a doctor.

If pregnant or breast-feeding, 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 room temperature 68° to 77°F (20 to 25°C); excursion permitted to 58°F to 86°F (15° to 30°C)

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, Glyceryl Stearate , Hydrogenated Polydecene, Hydroxypropylcellulose, Isobutylparaben, Lavandula Angustifolia (Lavender) Flower Extract, Methylparaben, PEG 100, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Sodium Lactate, Sodium Polyacrylate, Trideceth-6, Xanthan Gum

Questions or comments?

(210) 944-6920

HOW SUPPLIED

Lidocaine HCI 4% Cream

NDC: 73352-204-60

1oz. (30g) tube

MANUFACTURED FOR:

Trifluent Pharma, LLC

San Antonio, TX 78213

204-60

REV01 08/2025

KEEP OUT OF REACH OF CHILDREN

KEEP out of reach of children. If swallowed, get medical help anor contact a Poison control Center (1-800-222-1222) right aways.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE HCI 
lidocaine hci cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73352-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE 100 (UNII: RO266O364U)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
WHITE WAX (UNII: 7G1J5DA97F)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SODIUM LACTATE (UNII: TU7HW0W0QT)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
SAFFLOWER SEED (UNII: 8FCL6A31TX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73352-204-60	30 g in 1 TUBE; Type 0: Not a Combination Product	01/09/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/09/2026

Labeler - Trifluent Pharma, LLC (117167281)