LIDOCAINE 4% TOPICAL ANESTHETIC CREAM- lidocaine 4% cream

Lidocaine 4% Topical Anesthetic Cream by

Drug Labeling and Warnings

Lidocaine 4% Topical Anesthetic Cream by is a Otc medication manufactured, distributed, or labeled by Oncor Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredients

Lidocaine 4% w/w

Purpose

Topical Anesthetic

Uses

Temporarily relieves pain and itching due to:

• Minor cuts
• Minor scrapes
• Sunburn
• Minor burns
• Minor skin irritations
• Insect bites

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.

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

• Adults and children 2 years and older: apply externally to the affected area up to 3-4 times daily.
• Children under 2 years of age: consult a physician.

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

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

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)

INGREDIENTS AND APPEARANCE

LIDOCAINE 4% TOPICAL ANESTHETIC CREAM 
lidocaine 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83720-523
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83720-523-01	1 in 1 CARTON	05/22/2024
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	05/22/2024

Labeler - Oncor Pharmaceuticals (119032580)

Registrant - Oncor Pharmaceuticals (119032580)