LIDOCAINE CREAM- lidocaine cream

Lidocaine Cream by

Drug Labeling and Warnings

Lidocaine Cream by is a Otc medication manufactured, distributed, or labeled by Invernis Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purposes

Topical Analgesic

Uses

For the temporary relief of pain and itching, associated with minor burns,sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

Warnings

• For External Use only
• Avoid contact with the 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 occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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, 20 – 25°C (68-77°F).

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE,Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate-20,Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Triethanolamine.

Product label

INGREDIENTS AND APPEARANCE

LIDOCAINE CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85690-078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85690-078-60	60 g in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/02/2025

Labeler - Invernis Pharmaceuticals, Inc. (119500188)