SHEFFIELD LIDOCAINE- lidocaine cream

Sheffield Lidocaine by

Drug Labeling and Warnings

Sheffield Lidocaine by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine  4%

Purpose

Topical anesthetic

Uses

• Temporarily relieves minor pain

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

• 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

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

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 - Carton

Sheffield    NDC: 11527-191-30

4% Lidocaine

Topcial Anestheic Cream 

NET WT. 30g (1.06 oz)

INGREDIENTS AND APPEARANCE

SHEFFIELD LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-191-30	1 in 1 CARTON	12/22/2020
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/22/2020

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(11527-191)