Active Ingredients

Lidocaine HCl 4%

Purpose

External Anesthetic

Uses

For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburns, and minor burns.

Warning

For external use only.

Avoid contact with eyes

Stop using this product and ask doctor If

symptoms last for more than seven days, or clear up and occur again within a few days
if redness, irritation, swelling, pain or other symptoms increase

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.

Additional Information

Store at room temperature.

Inactive Ingredients

Aqua (Deionized Water), C13-14 Isoparaffin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Methylisothiazolinone, Polyacrylamide, Stearic Acid.

Principal Display Panel

NDC 76420-451-01

Xolido XP 4%

Pain Relief Cream

4 OZ (118 mL)

Distributed by:

Enovachem Manufacturing

Torrance, CA 90501

(310) 218-4146

Principal Display Panel

XOLIDO
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76420-451
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76420-451-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2013	10/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/05/2013	10/05/2023

Labeler - Asclemed USA, Inc (059888437)

Revised: 10/2023

Document Id: 0706a300-36e3-9d8b-e063-6294a90a54dd

Set id: e29c46ce-6758-41ff-af1a-e99fb67a8c33

Version: 5

Effective Time: 20231006

Asclemed USA, Inc