LIDOCAINE 4% CREAM- lidocaine cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

Temporarily relieves pain and itching due to:

• minor cuts
• sunburn
• minor scrapes
• minor burns
• insect bites
• minor skin irritations

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
• do not use If pregenant or breastfeeding.

Keep out of reach of children.

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

DIRECTIONS

Adults and children 2 years and older:

apply externally to the affected area up to 3 to 4 times a day

Adults and children 12 years and older:

Apply externally to the affected area up to 6 times a day.

children under 2 years ask a doctor

OTHER INFORMATION

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature

INACTIVE INGREDIENTS

STEARIC ACID , GLYCERYL-STEARATE, PEG-100 STEARATE , SODIUM POLYACRYLATE , GLUCOSAMINE SULFATE , TROLAMINE , LAURETH, ISOSTEARYL PALMITATE, PROPYLENE GLYCOL , DIMETHYL SULFONE , C13-14 ISOPARAFFIN, PHENOXYETHANOL, POLYACRYLAMIDE, CETOSTEARYL ALCOHOL , CHONDROITIN SULFATE , Pure Water, Peppermint oil

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

Manufactured For:

Medcore LLC 3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-419-30

Lidocaine 4%
Topical Anesthetic Cream

Medcore LLC

30 gram

INGREDIENTS AND APPEARANCE

LIDOCAINE 4% CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82461-419
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
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
PEG-100 MONOSTEARATE (UNII: YD01N1999R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
TROLAMINE (UNII: 9O3K93S3TK)
LAURETH-7 (UNII: Z95S6G8201)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEPPERMINT OIL (UNII: AV092KU4JH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82461-419-30	1 in 1 BOX	05/04/2026
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	05/04/2026

Labeler - Medcore LLC (069802634)