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 2%

Purpose

External Anaesthetic

Uses

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

Warnings

•   - For external Use only
•   - Avoid contact with eyes.

•   - If symptoms persist for more than seven days, or clear up and occur again within a few day, discontinue use and consult physician.

•   - If redness, irritation, swelling, pain or other symptoms increase, discontinue use and consult physician.

•   - Keep out of reach of children.  If swallowed, consult physician.

Directions

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

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

Xolido 2%

Pain Relief Cream

4 oz (118 mL)

Distributed by:

Enovachem

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

INGREDIENTS AND APPEARANCE

XOLIDO 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76420-449
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 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: 76420-449-60	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)