LIDOCAINE 4% TOPICAL ANESTHETIC CREAM- lidocaine 4% cream 
Oncor Pharmaceuticals

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Lidocaine 4% Cream

Drug Facts
Active Ingredients

Lidocaine 4% w/w

Purpose

Topical Anesthetic

Uses

Temporarily relieves pain and itching due to:

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Keep out of reach of children

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

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7900 or FDA at 1-800-FDA-1088.

Directions

Lidocaine
4% Cream

Inactive Ingredients

Cetyl alcohol, Citric acid, Glycerin, Glyceryl stearate SE, Mineral oil, PEG-100 stearate, Phenoxyethanol, Purified water, Stearyl alcohol, White
petrolatum, Xanthan gum.

See crimp of tube or carton for lot and exp. date.

RETAIN CARTON FOR COMPLETE DRUG FACTS.

Other information

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

Manufactured In USA For :

ONCOR PHARMACEUTICALS
8815 Center Park Dr Suite 430
Columbia
Maryland 21045
Rev. 05/24

Package Label

ONCOR PHARMACEUTICALS

NDC 83720- 523-01

Lidocaine 4% Cream

Topical Anesthetic Cream

For External Use Only
Not For Ophthalmic Use

This product contains child-resistant
packaging. To open, push down on the cap of the tube while turning and lift off.

NET WT. 1.05 OZ. (30 gm)

Carton

ONCOR PHARMACEUTICALS

NDC 83720- 523-01

Lidocaine 4% Cream

Topical Anesthetic Cream

For External Use Only
Not For Ophthalmic Use

This product contains child-resistant
packaging. To open, push down on the cap of the tube while turning and lift off.

NET WT. 1.05 OZ. (30 gm)

Tube

LIDOCAINE 4% TOPICAL ANESTHETIC CREAM 
lidocaine 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83720-523
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83720-523-011 in 1 CARTON05/10/2024
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 DrugM01705/10/2024
Labeler - Oncor Pharmaceuticals (119032580)
Registrant - Oncor Pharmaceuticals (119032580)

Revised: 5/2024
Document Id: 181cfed3-19e1-7c69-e063-6394a90a067a
Set id: 1baaa669-05af-4024-a0ba-ee3451756f6a
Version: 2
Effective Time: 20240510
 
Oncor Pharmaceuticals