SHEFFIELD LIDOCAINE- lidocaine cream 
Sheffield Pharmaceuticals LLC

----------

Sheffield Pharaceutical Lidocaine Cream 

Drug Facts

Active ingredient

Lidocaine  4%

Purpose

Topical anesthetic

Uses

Warnings

For external use only

Do not use

  • on large areas of the body or on cut,irritated or swollen skin
  • on puncture wounds
  • for more than one week without consultanting a doctor

When using this product

use only as directed. read and follow all directions and warnings on this carton.

do notallow contact with the eyes

do not bandage or apply local heat (such as heating pads) to the area of use.

Stop use and ask a doctor if

  • condition worsens
  • symptons persist for more than 7 days or clear up and occur again within a few days.
  • If pregnant or breast feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children and pets.

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

Directions

Other information

Inactive ingredients

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Polysorbate 80,  Propylene Glycol, Tocopheryl Acetate, Trolamine, Water (purified)

Questions?(

Principal Panel-Tube

Sheffield  NDC 11527-191-30

4% Lidocaine

Topical Anesthetic Cream

NET WT. 30g (1.06 oz)

Principal Panel-Tube

Principal Panel-Tube

Principal Panel - Carton

Sheffield    NDC 11527-191-30

4% Lidocaine

Topcial Anestheic Cream 

NET WT. 30g (1.06 oz)

Lidocaine 30g Carton

Lidocaine 30g Carton
SHEFFIELD LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-191
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-191-301 in 1 CARTON12/22/2020
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/22/2020
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(11527-191)

Revised: 11/2023
Document Id: f954502b-f7c0-4f72-a9bc-32b11b28b053
Set id: 22c9bcdc-3f80-4871-b79f-8a32eebec9e3
Version: 2
Effective Time: 20231130
 
Sheffield Pharmaceuticals LLC