Lidocaine Cream by Invernis Pharmaceuticals, Inc.

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]

LIDOCAINE CREAM- lidocaine cream 
Invernis Pharmaceuticals, Inc.

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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. 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

image description

LIDOCAINE CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 85690-078
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 85690-078-6060 g in 1 BOTTLE; Type 0: Not a Combination Product06/02/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/02/202512/31/2025
Labeler - Invernis Pharmaceuticals, Inc. (119500188)

Revised: 12/2025
Document Id: 46b6e0d3-e82f-c78b-e063-6394a90a6d5b
Set id: cd350eff-6f1a-4181-80ab-1f71403845e6
Version: 2
Effective Time: 20251224