LIDOCAINE 5% CREAM- lidocaine cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient

Lidocaine 5% w/w

Purpose

Topical anesthetic

Uses

For the temporary relief of local pain, soreness, burning, itching or discomfort associated with anorectal disorders.

Warnings

For external use only.

When using this product

• avoid contact with eyes
• do not exceed recommended daily dosage unless directed by a physician
• do not put this product into the rectum by using fingers or any mechanical device or applicator.
• in case of bleeding, consult a doctor promptly

Keep out of reach of children.

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

DIRECTIONS

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. Children under 12 years of age: Consult 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,Magnesium Sulfate Unspecified, Laureth,Isopropyl Myristate,C13-14 Isoprraffin, Sunflower Oil,Glycyrrhiza Glabra,Paraguay holly extract,Phenoxyethanol,Glyceryl-Steatate, Polyacrylamide,Lemon oil,Water,Peppermint oil.

Stop use and ask a doctor if

• allergic reaction occurs
• condition worsens or does not improve within 7 days
• symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
• symptoms clear up and return within a few days
• if pregnant or breastfeeding

Manufactured For:

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

PRINCIPAL DISPLAY PANEL

NDC: 82461-420-30

Lidocaine 5%
Topical Anesthetic Anorectal Cream

Medcore LLC

30 gram

INGREDIENTS AND APPEARANCE

LIDOCAINE 5% CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82461-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER (UNII: 2788Z9758H)
LAURETH-7 (UNII: Z95S6G8201)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
PEPPERMINT OIL (UNII: AV092KU4JH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
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: 82461-420-30	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)