LIDOCAINE - lidocaine cream 
Nivagen Pharmaceuticals, Inc.

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Lidocaine 5%



Drug Facts

Active Ingredient 

Lidocaine 5% w/w

Purpose

Topical anesthetic

Uses

Temporarily relieves the pain and itching due to anorectal disorders.

Warnings

For external use only.

When using this product 

Stop use and ask a doctor if 

Keep out of reach of children.

 If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Verolec HE 60, Benzyl Alcohol, Polysorbate 80, Triethanolamine, Vitamin E- Acetate, Carbomer 940, Isopropyl Myristate, Propylene Glycol, Water   

Questions?

1-877-977-0687

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

NDC 75834-333-30

Lidocaine 5%

Topical Anesthetic Cream-Anorectal


NIVAGEN

net wt. 30 g (1 oz)
 



carton-label

 

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75834-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TRIETHANOLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75834-333-3030 g in 1 TUBE; Type 0: Not a Combination Product01/05/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM01501/05/2025
Labeler - Nivagen Pharmaceuticals, Inc. (052032418)

Revised: 1/2025
Document Id: 8ab252ef-f8ee-442b-bcf4-a44c57448cba
Set id: 32964ec3-1880-477b-9f71-2222c39106aa
Version: 2
Effective Time: 20250123
 
Nivagen Pharmaceuticals, Inc.