4 LIDOCAINE TOPICAL ANESTHETIC- lidocaine cream 
RUGBY LABORATORIES

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4% Lidocaine Topical Anesthetic Cream

Drug Facts

Active ingredient

Lidocaine 4% W/W

Purpose

Topical Analgesic

Uses

temporarily relieves pain and itching due to:

Warnings

For external use only.

When using this product

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

  • Allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Do not use

over large areas of the body.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredient

aloe barbadensis leaf extract, benzyl alcohol, carbomer homopolymer, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid

Questions or comments?

1-800-639-3803

Package Labeling:

Outer Package03Inner Package03

4 LIDOCAINE TOPICAL ANESTHETIC 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1267
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1267-2015 g in 1 BOX; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/30/2020
Labeler - RUGBY LABORATORIES (079246066)
Registrant - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

Revised: 6/2025
Document Id: 389094cf-5a17-0699-e063-6294a90a6791
Set id: 63327e57-f4c8-4ae6-9d28-cef8697bbdcc
Version: 3
Effective Time: 20250627
 
RUGBY LABORATORIES