XOLIDO- lidocaine hcl cream

XOLIDO by

Drug Labeling and Warnings

XOLIDO by is a Otc medication manufactured, distributed, or labeled by Asclemed USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

INGREDIENTS AND APPEARANCE

XOLIDO 
lidocaine hcl cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/05/2013

Labeler - Asclemed USA, Inc (059888437)