Sheffield Pharaceutical Lidocaine Cream

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-11-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:19:29

Label at a glance#

ProductSheffield Lidocaine
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

Adults and children over 12 years:  apply a thin layer ot affected area every 6 t o8 hours, not to exceed 3 applications in a 24 hour period Children under 12 years  or younger: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine  4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over 12 years: 
  • apply a thin layer ot affected area every 6 t o8 hours, not to exceed 3 applications in a 24 hour period
  • Children under 12 years  or younger: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Panel-Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield  NDC 11527-191-30

4% Lidocaine

Topical Anesthetic Cream

NET WT. 30g (1.06 oz)

Principal Panel-TubePrincipal Panel-Tube

Principal Panel-Tube
Principal Panel-Tube

Principal Panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield    NDC 11527-191-30

4% Lidocaine

Topcial Anestheic Cream 

NET WT. 30g (1.06 oz)

Lidocaine 30g CartonLidocaine 30g Carton

Lidocaine 30g Carton
Lidocaine 30g Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11527-19111527-191-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4032d16d-7296-4ea8-ae9c-7b8672b5de9722c9bcdc-3f80-4871-b79f-8a32eebec9e32025-04-12WarningsExact identifier
spl set id: 22c9bcdc-3f80-4871-b79f-8a32eebec9e3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.