4 LIDOCAINE TOPICAL ANESTHETIC- lidocaine cream 
RUGBY LABORATORIES

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4% Lidocaine Topical Anesthetic Cream

Drug Facts

Active ingredient

Active ingredient

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 apply 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 ingredients

aloe barbadensis leaf extract, benzyl alcohol, carbomer 940, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid, trolamine

Questions & Comments?

1-800-645-2158

Package Labeling:

Label

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 TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
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)

Revised: 10/2023
Document Id: 0883340e-4a26-6eb2-e063-6294a90aabe0
Set id: 63327e57-f4c8-4ae6-9d28-cef8697bbdcc
Version: 2
Effective Time: 20231024
 
RUGBY LABORATORIES